Coherus Announces Six-Year JUPITER-02 Follow-up Results Showing LOQTORZI® plus Chemotherapy Nearly Doubles Median Overall Survival in Nasopharyngeal Carcinoma

Rhea-AI Summary

Coherus (NASDAQ: CHRS) reported six-year follow-up from the Phase 3 JUPITER-02 trial showing LOQTORZI (toripalimab-tpzi) plus gemcitabine and cisplatin achieved a median overall survival of 64.8 months vs 33.7 months for chemotherapy alone (31-month improvement; HR 0.62; 95% CI 0.45–0.85).

Results presented at ESMO Asia 2025 reinforce LOQTORZI plus chemotherapy as a first-line option for recurrent or metastatic nasopharyngeal carcinoma and summarize key safety findings including immune-mediated adverse events.

Positive

• Median OS 64.8 months with LOQTORZI plus chemotherapy
• Median OS 33.7 months with chemotherapy alone (comparison)
• HR 0.62 indicating 38% reduction in risk of death

Negative

• Hypothyroidism occurred in 30% of combo-treated patients
• Immune-mediated dermatologic events in 8% of combo arm
• Immune-mediated pneumonitis in 2.1% of combo-treated patients
• Infusion-related reactions reported in 4.1% of combo-treated patients

News Market Reaction

+6.67%

9 alerts

+6.67% News Effect

+7.3% Peak in 1 hr 5 min

+$10M Valuation Impact

$163M Market Cap

0.3x Rel. Volume

On the day this news was published, CHRS gained 6.67%, reflecting a notable positive market reaction. Argus tracked a peak move of +7.3% during that session. Our momentum scanner triggered 9 alerts that day, indicating moderate trading interest and price volatility. This price movement added approximately $10M to the company's valuation, bringing the market cap to $163M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Median OS (combo): 64.8 months Median OS (chemo): 33.7 months OS improvement: 31-month increase +5 more

8 metrics

Median OS (combo) 64.8 months LOQTORZI plus gemcitabine/cisplatin arm in Phase 3 JUPITER-02 RM-NPC

Median OS (chemo) 33.7 months Chemotherapy-alone arm in Phase 3 JUPITER-02 RM-NPC

OS improvement 31-month increase Difference in median overall survival vs chemotherapy alone

Hazard ratio HR 0.62 (95% CI 0.45–0.85) Observed reduction in risk of death with LOQTORZI plus chemotherapy

Pneumonitis (combo) 2.1% (3/146) patients Immune-mediated pneumonitis with LOQTORZI plus cisplatin and gemcitabine

Pneumonitis (mono) 2.6% (22/851) patients Immune-mediated pneumonitis with LOQTORZI monotherapy

Hypothyroidism (combo) 30% (44/146) patients Immune-mediated hypothyroidism with LOQTORZI plus cisplatin and gemcitabine

Hyperthyroidism (mono) 7% (55/851) patients Immune-mediated hyperthyroidism with LOQTORZI monotherapy

Market Reality Check

Price: $1.63 Vol: Volume 1,015,597 shares i...

normal vol

$1.63 Last Close

Volume Volume 1,015,597 shares is about 0.79x the 20-day average of 1,287,111, suggesting no pre-news accumulation signal. normal

Technical Shares at $1.20 are trading slightly above the $1.11 200-day moving average but remain 38.46% below the 52-week high of $1.95.

Peers on Argus

CHRS fell 2.44% with several oncology peers also down (e.g., AGEN -3.2%, GLSI -2...

CHRS fell 2.44% with several oncology peers also down (e.g., AGEN -3.2%, GLSI -2.4%, TIL -3.7%, MCRB -6.3%), while THTX rose 0.89%, indicating a generally weak but mixed biotech tape.

Historical Context

5 past events · Latest: Nov 07 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Nov 07	Clinical data update	Positive	-10.1%	Phase 1b CHS-114 biomarker and safety data in recurrent/metastatic HNSCC.
Nov 06	Quarterly earnings	Negative	-4.8%	Q3 2025 results with LOQTORZI revenue growth but sizable net loss.
Nov 06	Management change	Positive	-4.8%	Appointment of Chief Strategy and Corporate Affairs Officer to support growth.
Oct 30	Earnings preview	Neutral	-1.7%	Announcement of upcoming Q3 2025 results call and webcast details.
Oct 23	Investor conferences	Neutral	-0.6%	Planned presentations at multiple healthcare investor conferences in Q4 2025.

Pattern Detected

Recent history shows CHRS often trading lower on both positive clinical updates and corporate news, with more consistent alignment only around earnings and routine corporate communications.

Recent Company History

Over the last few months, Coherus Oncology has focused on LOQTORZI and its immuno-oncology pipeline. On Nov 6, 2025, Q3 results showed LOQTORZI net revenue of $11.2M and a net loss of $(44.5)M, followed by additional disclosures via 10-Q and 8-K. The company also strengthened leadership with a new Chief Strategy and Corporate Affairs Officer on Nov 6. Earlier, it highlighted clinical biomarker data for CHS-114 on Nov 7. Despite these milestones, shares generally moved lower after each event, framing today’s positive survival data against a backdrop of cautious trading.

Regulatory & Risk Context

Active S-3 Shelf · $150.0 million

Shelf Active

Active S-3 Shelf Registration 2025-11-13

$150.0 million registered capacity

An effective Form S-3 shelf filed on Nov 13, 2025 allows Coherus to issue up to $150.0 million of mixed securities over time, enabling flexible capital raises via underwritten offerings, agents, or direct sales as detailed in future prospectus supplements.

Market Pulse Summary

The stock moved +6.7% in the session following this news. A strong positive reaction aligns with the...

Analysis

The stock moved +6.7% in the session following this news. A strong positive reaction aligns with the substantial efficacy signal, with median overall survival reaching 64.8 months versus 33.7 months on chemotherapy alone and a hazard ratio of 0.62. Historically, CHRS sold off after positive clinical updates, so a sustained move would mark a behavioral shift. Investors would need to weigh this against the company’s $150.0 million shelf capacity, which enables future equity or debt issuance that could affect longer-term valuation dynamics.

Key Terms

overall survival, phase 3, hazard ratio, pd-1 inhibitor, +4 more

8 terms

overall survival medical

"announced compelling six-year overall survival (OS) follow-up results from the Phase 3"

Overall survival is the average or median length of time patients remain alive after starting a treatment or entering a clinical study, measured regardless of cause of death. Investors care because it is a clear, hard measure of a therapy’s real-world benefit — like timing how long a new battery actually runs — and strong improvements in overall survival can drive regulatory approval, market adoption and revenue potential.

phase 3 medical

"overall survival (OS) follow-up results from the Phase 3 JUPITER-02 trial evaluating"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

hazard ratio medical

"representing a 31-month improvement and an observed 38% reduction in risk of death (HR 0.62;"

A hazard ratio is a way scientists compare the chance of something happening over time between two groups, like patients taking different medicines. If the ratio is high, it means one group is more likely to experience the event sooner or more often, which helps determine how effective a treatment is or how risky a situation might be.

pd-1 inhibitor medical

"LOQTORZI, Coherus’ next-generation PD-1 inhibitor, is an important part of this vision"

A PD-1 inhibitor is a type of medicine that helps the immune system recognize and attack cancer cells by blocking the PD-1 checkpoint—a molecular “off switch” that cancer can use to hide from immune defenses. For investors, these drugs matter because they can transform treatment options, drive sales or partnerships, and affect a company’s valuation if clinical trials, approvals, or competitive positioning change; think of them as unlocking a locked door to let the body’s defenses work.

immune-mediated medical

"Severe and Fatal Immune-Mediated Adverse ReactionsImmune-mediated adverse reactions listed herein"

Immune-mediated describes a condition or reaction caused by the body's immune system attacking something it views as a threat, which can include infections, healthy tissue or a medication. For investors, labeling a drug effect or disease as immune-mediated signals a specific biological cause that often requires targeted testing, safety monitoring and tailored treatments, affecting clinical development risks, regulatory review and market acceptance—like knowing whether a product problem is a manufacturing defect versus user error.

pneumonitis medical

"Immune-Mediated PneumonitisLOQTORZI can cause immune-mediated pneumonitis."

Pneumonitis is inflammation of the lungs that damages the small air sacs and surrounding tissue, causing coughing, shortness of breath, and reduced oxygen exchange. For investors, it matters because it can be a serious safety signal for drugs, medical devices, or treatments, potentially delaying approvals, prompting label warnings, leading to costly additional studies, or reducing market adoption — similar to a product recall that erodes confidence and sales.

hypophysitis medical

"HypophysitisLOQTORZI can cause immune-mediated hypophysitis."

Inflammation of the pituitary gland, the small “conductor” at the base of the brain that controls many body hormones. It can disrupt hormone balance, cause lasting health needs, and sometimes require treatment or ongoing monitoring. For investors, hypophysitis matters because it can signal safety risks for drugs or medical devices, lead to regulatory reviews, trial delays, label warnings, or unexpected costs that affect a company’s financial outlook.

toxic epidermal necrolysis medical

"including Stevens-Johnson Syndrome (SJS), drug rash with eosinophilia and systemic symptoms (DRESS), and toxic epidermal necrolysis (TEN)"

A life‑threatening, rare reaction in which large areas of the skin and inner linings (like the mouth and eyes) slough off and die, often triggered by certain medications or infections; it resembles having a severe burn over much of the body. For investors, it matters because a confirmed case linked to a drug can halt clinical trials, prompt regulatory warnings or withdrawals, cause expensive legal claims, and materially damage a company’s sales and valuation.

AI-generated analysis. Not financial advice.

-6 Years Long-term survival data reinforce potential benefit to patient survival in treating recurrent or metastatic nasopharyngeal carcinoma with LOQTORZI in combination with chemotherapy -

REDWOOD CITY, Calif., Dec. 08, 2025 (GLOBE NEWSWIRE) -- Coherus Oncology, Inc. (NASDAQ: CHRS) today announced compelling six-year overall survival (OS) follow-up results from the Phase 3 JUPITER-02 trial evaluating LOQTORZI® (toripalimab-tpzi) plus chemotherapy in recurrent or metastatic nasopharyngeal carcinoma (RM-NPC). The findings reveal a striking and durable survival advantage that underscores the urgent clinical need to incorporate LOQTORZI with chemotherapy as first-line treatment.

In this exploratory post-hoc analysis, patients receiving LOQTORZI plus gemcitabine and cisplatin achieved a median OS of 64.8 months, nearly double that of chemotherapy alone (33.7 months), representing a 31-month improvement and an observed 38% reduction in risk of death (HR 0.62; 95% CI, 0.45–0.85). These results, presented at ESMO Asia 2025, signal a step change in cancer patient survival, reinforcing LOQTORZI’s role in transforming outcomes for people living with RM-NPC.

JUPITER-02 is a randomized, double-blind, placebo-controlled Phase 3 study evaluating LOQTORZI with chemotherapy in first-line RM-NPC, and this long-term follow-up provides additional context for the previously reported survival outcomes.

A Meaningful Shift for Patients Who Need It Most

RM-NPC is an aggressive cancer, and long-term survival with standard chemotherapy can be limited for many patients. The multi-year survival observed in the LOQTORZI arm suggests a potential for meaningful clinical benefit, which may translate into longer survival for patients who typically face a challenging prognosis.

“The new 6-year overall survival follow up data gives us even greater confidence to use toripalimab in patients with NPC that is recurrent or metastatic,” said Victoria Villaflor, MD, Professor and Director, Head and Neck Oncology Program, Division of Hematology-Oncology, Department of Medicine, UC Irvine School of Medicine.

For many patients, the difference between 33 months and nearly 65 months represents the possibility of more time with family and more milestones. This meaningful extension highlights why oncologists may consider adding LOQTORZI to chemotherapy upfront, as delaying or omitting a therapy associated with improved survival outcomes could reduce a patient’s opportunity to achieve longer-term benefit.

A Standard of Care Reinforced by Long-Term Evidence

“These data suggest a significant long-term overall survival benefit for patients living with RM-NPC,” said Rosh Dias, MD, Chief Medical Officer, Coherus Oncology. “With these long-term data, LOQTORZI, in combination with chemotherapy, reinforces the data supporting this regimen as the standard of care for patients living with RM-NPC.”

Coherus Oncology is advancing a pipeline built on deep scientific expertise and strategic collaborations designed to deliver first- and best-in-class therapies. LOQTORZI, Coherus’ next-generation PD-1 inhibitor, is an important part of this vision, with data indicating its potential to enhance survival outcomes when used with chemotherapy.

ESMO Asia 2025 Presentation Details
Abstract # 1279: Long Term Overall Survival Follow-up of Toripalimab versus Placebo in Combination with Gemcitabine and Cisplatin as First-line Treatment for Recurrent or Metastatic Nasopharyngeal Carcinoma

• Date: Friday, December 5, 2025, 5:00 p.m. – 6:30 p.m. PST
  

INDICATIONS AND IMPORTANT SAFETY INFORMATION

INDICATIONS

LOQTORZI® (toripalimab-tpzi) is indicated:

• In combination with cisplatin and gemcitabine, for the first-line treatment of adults with metastatic or with recurrent, locally advanced nasopharyngeal carcinoma (NPC).
• As a single agent, for the treatment of adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy.

IMPORTANT SAFETY INFORMATION

Severe and Fatal Immune-Mediated Adverse Reactions
Immune-mediated adverse reactions listed herein may not include all possible severe and fatal immune-mediated adverse reactions. Immune-mediated adverse reactions, which can be severe or fatal, occur in any organ system or tissue, affect more than one body system simultaneously, and occur at any time after starting PD-1/PD-L1 blocking antibody. While immune-mediated adverse reactions usually manifest during treatment, they can also manifest after discontinuation of PD-1/PD-L1 blocking antibodies.

• Monitor for early identification and management. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.
• Withhold or permanently discontinue LOQTORZI based on severity and type of reaction (see Dosage and Administration in Prescribing Information). In general, If LOQTORZI requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy.

Immune-Mediated Pneumonitis
LOQTORZI can cause immune-mediated pneumonitis.

• In patients receiving LOQTORZI in combination with cisplatin and gemcitabine, immune-mediated pneumonitis occurred in 2.1% (3/146) of patients, including Grade 2 (1.4%) adverse reactions. Pneumonitis resolved in 67% (2/3) of these patients.
• In patients receiving LOQTORZI monotherapy, immune-mediated pneumonitis occurred in 2.6% (22/851) of patients, including fatal (0.2%), Grade 3 (0.7%), and Grade 2 (1.1%) adverse reactions. Systemic corticosteroids were required in 82% (18/22) of patients with pneumonitis. Pneumonitis led to permanent discontinuation of LOQTORZI in 1.2% (10/851) of patients. Pneumonitis resolved in 23% (5/22) of these patients.

Immune-Mediated Colitis
LOQTORZI can cause immune-mediated colitis, which may present with diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. In patients receiving LOQTORZI monotherapy, immune-mediated colitis occurred in 0.4% (3/851) of patients, including Grade 3 (0.2%) and Grade 2 (0.1%) adverse reactions. Colitis resolved in all 3 patients.

Hepatotoxicity and Immune-Mediated Hepatitis
LOQTORZI can cause immune-mediated hepatitis.

• In patients receiving LOQTORZI in combination with cisplatin and gemcitabine, immune-mediated hepatitis occurred in 0.7% (1/146) of patients, which was a Grade 3 (0.7%) adverse reaction. The patient with immune-mediated hepatitis required systemic corticosteroids.
• In patients receiving LOQTORZI monotherapy, immune-mediated hepatitis occurred in 3.3% (28/851) of patients, including Grade 4 (0.8%), Grade 3 (2.1%), and Grade 2 (0.4%) adverse reactions. Hepatitis led to permanent discontinuation of LOQTORZI in 1.1% of patients and withholding of LOQTORZI in 0.8% of patients. Hepatitis resolved in 54% (15/28) of these patients.

Immune-Mediated Endocrinopathies
Adrenal Insufficiency
LOQTORZI can cause primary or secondary adrenal insufficiency. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Withhold or permanently discontinue LOQTORZI depending on severity. In patients receiving LOQTORZI monotherapy, adrenal insufficiency occurred in 0.5% (4/851) of patients, including Grade 2 (0.4%) and Grade 1 (0.1%) adverse reactions. Systemic corticosteroids were required in 75% (3/4) of the patients with adrenal insufficiency. Adrenal insufficiency led to withholding of LOQTORZI in 0.1% (1/851) of patients. In the one patient in whom LOQTORZI was withheld, LOQTORZI was reinitiated after symptom improvement.

Hypophysitis
LOQTORZI can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effects such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism. Initiate hormone replacement as indicated. Withhold or permanently discontinue LOQTORZI depending on severity. In patients receiving LOQTORZI monotherapy, hypophysitis occurred in 0.4% (3/851) of patients receiving LOQTORZI, including Grade 3 (0.2%) and Grade 2 (0.1%) adverse reactions. All three patients received systemic corticosteroids. Hypophysitis led to permanent discontinuation of LOQTORZI in 0.1% (1/851) of patients and withholding of LOQTORZI in 0.1% (1/851) of patients. The one patient in whom LOQTORZI was withheld reinitiated LOQTORZI.

Thyroid Disorders
LOQTORZI can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated. Withhold or permanently discontinue LOQTORZI depending on severity.

• In patients receiving LOQTORZI in combination with cisplatin and gemcitabine, thyroiditis occurred in 2.1% (3/146) of patients receiving LOQTORZI, including Grade 2 (1.4%). Three patients required thyroid hormone replacement therapy. Thyroiditis resolved in one of the 3 patients. Hyperthyroidism occurred in 1.4% (2/146) of patients receiving LOQTORZI in combination with cisplatin and gemcitabine. Hyperthyroidism resolved in these 2 patients. Hypothyroidism occurred in 30% (44/146) of patients receiving LOQTORZI in combination with cisplatin and gemcitabine, including Grade 2 (24%) and Grade 1 (6%). Eighty percent of the 44 patients required thyroid hormone replacement therapy. LOQTORZI was withheld in 2.1% (3/146) of the patients. Of the 3 patients in whom LOQTORZI was withheld, 2 patients reinitiated LOQTORZI.
• In patients receiving LOQTORZI monotherapy, thyroiditis occurred in 0.6% (5/851) patients receiving LOQTORZI, including Grade 2 (0.1%). Two of these 5 patients received systemic corticosteroids and 2 required thyroid hormone replacement therapy. Thyroiditis resolved in 2 of the 5 patients. Hyperthyroidism occurred in 7% (55/851) of patients receiving LOQTORZI, including Grade 2 (1.9%). Hyperthyroidism resolved in 85% (47/55) of the patients. Hypothyroidism occurred in 15% (128/851) of patients receiving LOQTORZI, including Grade 2 (8%). Sixty three percent of the 128 patients required thyroid hormone replacement therapy. LOQTORZI was withheld in 0.5% of patients. Of the 4 patients in whom LOQTORZI was withheld, 3 patients reinitiated LOQTORZI.

Type 1 Diabetes Mellitus, which can present with Diabetic Ketoacidosis
Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. Withhold or permanently discontinue LOQTORZI depending on severity. In patients receiving LOQTORZI monotherapy, diabetes mellitus occurred in 0.9% (8/851) of patients receiving LOQTORZI, including Grade 4 (0.1%), Grade 3 (0.7%), and Grade 2 (0.1%). Diabetes mellitus led to permanent discontinuation in 0.4% of patients. Six of the 8 (75%) patients with diabetes mellitus required long-term insulin therapy.

Immune-Mediated Nephritis with Renal Dysfunction
LOQTORZI can cause immune-mediated nephritis.

• In patients receiving LOQTORZI in combination with cisplatin and gemcitabine, immune-mediated nephritis occurred in 0.7% (1/146) of patients receiving LOQTORZI. The one patient with immune-mediated nephritis (Grade 4) required systemic corticosteroids and nephritis led to discontinuation of LOQTORZI. Nephritis resolved in this patient.
• In patients receiving LOQTORZI monotherapy, immune-mediated nephritis occurred in 0.5% (4/851) of patients, including Grade 3 (0.5%) adverse reactions. Nephritis resolved in 75% (3/4) of these patients.

Immune-Mediated Dermatologic Adverse Reactions
LOQTORZI can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson Syndrome (SJS), drug rash with eosinophilia and systemic symptoms (DRESS), and toxic epidermal necrolysis (TEN), has occurred with PD-1/PD-L1 blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes. Withhold or permanently discontinue LOQTORZI depending on severity.

• In patients receiving LOQTORZI in combination with cisplatin and gemcitabine, immune-mediated dermatologic adverse reactions occurred in 8% (12/146) of patients, including Grade 3 (3.4%) and Grade 2 (1.4%) adverse reactions. Systemic corticosteroids were required in 25% (3/12) of the patients with immune-mediated dermatologic adverse reactions. Immune-mediated dermatologic adverse reactions led to permanent discontinuation of LOQTORZI in 2.1% (3) of patients. Immune-mediated dermatologic adverse reactions resolved in 92% (11/12) of these patients.
• In patients receiving LOQTORZI monotherapy, immune-mediated dermatologic adverse reactions occurred in 4% (34/851) of patients, including Grade 3 (0.4%) and Grade 2 (1.4%) adverse reactions. Immune-mediated dermatologic adverse reactions led to withholding of LOQTORZI in 0.4% (3) of the patients. Systemic corticosteroids were required in 12% (4/34) of the patients with immune-mediated dermatologic adverse reactions. Immune-mediated dermatologic adverse reactions resolved in 71% (24/34) of these patients.

Other Immune-Mediated Adverse Reactions
The following clinically significant immune-mediated adverse reactions occurred at an incidence of <1% (unless otherwise noted) in patients who received LOQTORZI or were reported with the use of other PD-1/PD-L1 blocking antibodies. Severe or fatal cases have been reported for some of these adverse reactions.

• Cardiac/Vascular: Myocarditis, pericarditis, vasculitis, pericardial effusion
• Nervous System: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy
• Ocular: Uveitis, iritis and other ocular inflammatory toxicities can occur. Some cases can be associated with retinal detachment. Various grades of visual impairment, including blindness, can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss.
• Gastrointestinal: Pancreatitis, to include increases in serum amylase and lipase levels, gastritis, duodenitis
• Musculoskeletal and Connective Tissue: Myositis/polymyositis, rhabdomyolysis (and associated sequelae, including renal failure), arthritis, polymyalgia rheumatica, dermatomyositis
• Endocrine: Hypoparathyroidism
• Hematologic/Immune: Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection, other transplant (including corneal graft) rejection
  

Infusion-Related Reactions
LOQTORZI can cause severe or life-threatening infusion-related reactions including hypersensitivity and anaphylaxis.

• In patients receiving LOQTORZI in combination with cisplatin and gemcitabine, infusion-related reactions have been reported in 4.1% of patients, including Grade 2 (0.7%) reactions.
• In patients receiving LOQTORZI monotherapy, infusion-related reactions occurred in 2% of 851 patients, including Grade 3 (0.1%) and Grade 2 (0.6%). LOQTORZI was withheld for one Grade 3 infusion related reaction. Monitor patients for signs and symptoms of infusion-related reactions including rigors, chills, wheezing, pruritus, flushing, rash, hypotension, hypoxemia, and fever. Interrupt or slow the rate of infusion for mild (Grade 1) or moderate (Grade 2) infusion-related reactions. For severe (Grade 3) or life-threatening (Grade 4) infusion-related reactions, stop infusion and permanently discontinue LOQTORZI.

Complications of Allogeneic Hematopoietic Stem Cell Transplant (HSCT)
Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/PD-L1 blocking antibody. Transplant-related complications include hyperacute graft-versus-host-disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between PD-1/PD-L1 blockade and allogeneic HSCT. Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with a PD-1/PD-L1 blocking antibody prior to or after an allogeneic HSCT.

Embryo-Fetal Toxicity
LOQTORZI can cause fetal harm when administered to a pregnant woman. Animal studies have demonstrated that inhibition of the PD-1/PD-L1 pathway can lead to increased risk of immune-mediated rejection of the developing fetus resulting in fetal death. Advise women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with LOQTORZI and for 4 months after the last dose.

Lactation
There are no data on the presence of toripalimab-tpzi in human milk; its effects on the breastfed child, or on milk production. Maternal IgG is known to be present in human milk. The effects of local gastrointestinal exposure and limited systemic exposure in the breastfed child to toripalimab-tpzi are unknown. Because of the potential for serious adverse reactions in breastfed children, advise lactating women not to breastfeed during treatment with LOQTORZI and for 4 months after the last dose.

Serious Adverse Reactions

• In JUPITER-02, when LOQTORZI was administered in combination with cisplatin and gemcitabine for the first-line treatment of recurrent, locally advanced or metastatic nasopharyngeal carcinoma, serious adverse reactions occurred in 43% of patients. Serious adverse drug reactions in ≥2% were thrombocytopenia (14%), neutrophil count decreased (10%), pneumonia (10%), anemia (9%), abnormal hepatic function (2.7%), and rash (2.1%). There were three fatal adverse reactions (2.1%): one due to epistaxis; one due to intracranial hemorrhage associated with immune-related thrombocytopenia and coagulopathy; and one due to pneumonia. Permanent discontinuation of LOQTORZI, due to an adverse reaction occurred in 12% of patients. Adverse reactions resulting in permanent discontinuation of LOQTORZI in ≥1% were pneumonia (2.1%), pulmonary tuberculosis (1.4%), rash (1.4%), and vomiting (1.4%). The most common Grade 3 to 4 laboratory abnormalities (≥2%) were decreased neutrophils (58%), decreased lymphocytes (57%), decreased hemoglobin (50%), decreased platelets (33%), decreased potassium (10%), decreased sodium (9%), increased alanine aminotransferase (6%), increased or decreased magnesium (4.2% each), decreased calcium (3.5%), increased aspartate aminotransferase (2.7%), and increased bilirubin (2.1%).
• In POLARIS-02, when LOQTORZI was administered as a single agent to patients with previously treated, unresectable or metastatic nasopharyngeal carcinoma, serious adverse reactions occurred in 24% of patients. Serious adverse drug reactions in ≥2% were pneumonia (4.7%), abnormal hepatic function (2.6%), and hyperbilirubinemia (2.1%). Fatal adverse reactions occurred in 3.7% of patients who received LOQTORZI, including death not otherwise specified (1.6%), tumor hemorrhage (0.5%), hepatic failure and thrombocytopenia (0.5%), hyponatremia (0.5%), and sudden death (0.5%). Permanent discontinuation of LOQTORZI due to an adverse reaction occurred in 9% of patients. Adverse reactions resulting in permanent discontinuation of LOQTORZI in ≥1% included pneumonia (1.1%), abnormal hepatic function (1.1%), and hyperbilirubinemia (1.1%). The most common Grade 3 or 4 laboratory abnormalities (≥2%), were decreased sodium (11%), decreased lymphocytes (9%), decreased hemoglobin (6%), increased aspartate aminotransferase (3.8%), decreased phosphate (3.2%), and increased alkaline phosphatase (2.2%).

Common Adverse Reactions

• In JUPITER-02, the most common adverse reactions (≥20%) were nausea (71%), vomiting (68%), decreased appetite (55%), constipation (39%), hypothyroidism (38%), rash (36%), pyrexia (32%), diarrhea (31%), peripheral neuropathy (30%), cough (26%), musculoskeletal pain (25%), upper respiratory infection (23%), insomnia (23%), dizziness (21%), and malaise (21%).
• In POLARIS-02, in patients with previously treated, unresectable or metastatic nasopharyngeal carcinoma, the most common (≥20%) adverse reactions were hypothyroidism (27%), fatigue (22%), and cough (20%).

LOQTORZI® Injection: 240 mg/6 mL (40 mg/mL) solution in a single-dose vial

Please see prescribing information for LOQTORZI.

About Coherus Oncology

Coherus Oncology is a fully integrated commercial-stage innovative oncology company with an approved next-generation PD-1 inhibitor, LOQTORZI^® (toripalimab-tpzi), and a pipeline that includes two mid-stage clinical candidates targeting liver, lung, head & neck, colorectal and other cancers. The Company’s strategy is to grow sales of LOQTORZI in NPC and advance the development of new indications for LOQTORZI in combination with both its pipeline candidates as well as through its partners, driving sales multiples and synergies from proprietary combinations.

Coherus’ innovative oncology pipeline includes multiple antibody immunotherapy candidates focused on enhancing the innate and adaptive immune responses to enable a robust antitumor response and enhance outcomes for patients with cancer. CHS-114 is a highly selective cytolytic anti-CCR8 antibody currently in Phase 1b/2a studies in patients with advanced solid tumors, including head and neck squamous cell carcinoma, colorectal cancer, gastric cancer, and esophageal cancer. Casdozokitug is a novel IL-27 antagonistic antibody currently being evaluated in a Phase 2 study in patients with first-line hepatocellular carcinoma.

For more information about LOQTORZI, including the U.S. Prescribing Information and important safety information, please visit www.loqtorzi.com.

Forward-Looking Statements

The statements in this press release include express or implied forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended about Coherus that involve risks and uncertainties relating to future events and the future performance of Coherus. Forward-looking statements relate to expectations, beliefs, projections, future plans and strategies, anticipated events or trends and similar expressions concerning matters that are not historical facts. Words such as “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “future,” “opportunity,” “likely,” “target,” variations of such words, and similar expressions or negatives of these words are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. You can also identify forward-looking statements by discussions of strategy, plans or intentions.

Examples of such forward-looking statements include, but are not limited to, express or implied statements regarding: the ability of Coherus’ pipeline to enhance outcomes for cancer patients; expectations about future synergies; projections about growth in sales; expectations for future enrollment in clinical trials; projections about the expansion of indications for LOQTORZI; and the assumptions underlying or relating to such statements.

These forward-looking statements are based on Coherus’ current plans, estimates and projections. Such forward-looking statements involve substantial risks and uncertainties that could cause actual results to differ materially from those contemplated in any forward-looking statements. Such risks and uncertainties include, without limitation: uncertainties about the potential impact of unforeseen liabilities, future capital expenditures, revenues, costs, expenses, earnings, economic performance, indebtedness, financial condition and losses on Coherus’ prospects, business and operations in the future; risks and uncertainties in executing collaboration agreements and other joint ventures; risks and uncertainties of conducting clinical trials; the risks of Coherus’ dependence on an ability to raise funds, which may not be available on acceptable terms or at all; and risks and uncertainties of any litigation, regulatory actions and other legal proceedings.

All forward-looking statements contained in this press release speak only as of the date of this press release. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further discussion of these and other factors that could cause Coherus’ future results to differ materially from any forward-looking statements see the section entitled “Risk Factors” in Coherus’ Quarterly Report on Form 10-Q for the period ended September30, 2025, filed with the Securities and Exchange Commission (SEC) on November 6, 2025, as updated by Coherus’ subsequent reports filed with the SEC.

LOQTORZI® is a registered trademark of Coherus Oncology, Inc.
©2025 Coherus Oncology, Inc. All rights reserved.

Coherus Oncology Contact Information:

For Investors:
Carrie Graham
VP, Investor Relations & Advocacy
IR@coherus.com

US-LOQ-0283.1  12/2025

FAQ

What did Coherus report from the JUPITER-02 six-year follow-up for CHRS?

LOQTORZI plus chemotherapy showed median OS 64.8 months versus 33.7 months for chemo alone (HR 0.62).

How much did LOQTORZI (CHRS) improve overall survival in RM-NPC at six years?

An observed 31-month median OS improvement and a 38% reduction in risk of death (HR 0.62).

Is LOQTORZI (CHRS) supported as first-line therapy for recurrent or metastatic NPC?

Long-term JUPITER-02 data reinforce LOQTORZI plus chemotherapy as a supported first-line option for RM-NPC.

What are key safety concerns for LOQTORZI plus chemo reported in the JUPITER-02 update?

Noted risks include hypothyroidism 30%, dermatologic events 8%, pneumonitis 2.1%, and infusion reactions 4.1%.

When and where were the JUPITER-02 six-year results for CHRS presented?

Data were presented at ESMO Asia 2025 (Abstract #1279) on December 5, 2025.