Biohaven Presents Clinical Safety and Efficacy Data for BHV-1510, a Next-Generation Trop2 Antibody Drug Conjugate in Combination with Cemiplimab at the 2025 European Society for Medical Oncology (ESMO) Immuno-Oncology Congress

Rhea-AI Summary

Biohaven (NYSE: BHVN) presented Phase 1 data for BHV-1510, a next‑generation Trop2 antibody‑drug conjugate, in combination with Regeneron’s anti‑PD‑1 cemiplimab at ESMO IO (Dec 10–12, 2025).

At the 2.5 mg/kg Q3W BHV‑1510 dose, confirmed objective response rate (ORR) was 72.7% with confirmed responses including 3/5 NSCLC (60%), 4/4 endometrial cancer (100%, including a CR) and 1/2 urothelial (50%). Across 23 efficacy‑evaluable participants the confirmed ORR was 52.2%. Median time to response was 11.1 weeks. Safety showed low rates of payload‑related toxicities, no interstitial lung disease, no treatment discontinuations for AEs, and a favorable PK with unconjugated payload payload‑to‑ADC molar ratio <1%.

Positive

• Confirmed ORR 72.7% at BHV‑1510 2.5 mg/kg Q3W
• Overall confirmed ORR 52.2% in 23 efficacy‑evaluable participants
• Responses across tumor types: NSCLC, endometrial (100% with CR), urothelial
• Median time to response of 11.1 weeks
• No interstitial lung disease and no AE‑related discontinuations
• Payload‑to‑ADC molar ratio <1% indicating high ADC stability

Negative

• Oral mucositis/stomatitis frequent: Q3W all‑grade 59.1%, Grade ≥3 22.7%
• Maximum tolerated dose not reached; limited DLT data (one Grade 3 stomatitis)
• Study population heavily pretreated: median two prior lines, 87.1% prior PD‑(L)1 exposure

Key Figures

ORR at 2.5 mg/kg 72.7% BHV-1510 2.5 mg/kg Q3W plus cemiplimab across tumor types

NSCLC ORR 3/5 (60%) NSCLC cohort at 2.5 mg/kg Q3W plus cemiplimab

Endometrial cancer ORR 4/4 (100%) Endometrial cancer cohort at 2.5 mg/kg Q3W plus cemiplimab

Overall ORR all doses 52.2% 23 efficacy-evaluable participants across BHV-1510 dose levels

Median time to response 11.1 weeks Participants treated with BHV-1510 plus cemiplimab

Participants treated 31 participants Total treated with BHV-1510 plus cemiplimab across regimens

Prior PD-(L)1 exposure 87.1% Share of participants previously treated with PD-(L)1 agents

Neutrophil decrease ≥Grade 3 12.9% Rate of high-grade neutrophil count decrease across all BHV-1510 doses

Market Reality Check

$11.53 Last Close

Volume Volume 2,677,558 vs 20-day average 4,262,521, indicating lighter-than-typical trading. low

Technical Trading below 200-day MA with price $10.60 versus MA $16.98, reflecting a longer-term downtrend.

Peers on Argus

Biotech peers showed mixed moves (e.g., SNDX +4.94%, PHVS -1.42%), suggesting this BHVN update is more stock-specific than part of a broad sector trend.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Nov 13	Equity offering close	Negative	+2.7%	Closed upsized equity offering generating about $200M in gross proceeds.
Nov 12	Equity offering pricing	Negative	-6.7%	Priced $175M common share offering at $7.50 per share.
Nov 11	Equity offering launch	Negative	+9.4%	Announced proposed $150M common share offering with underwriter option.
Nov 10	Earnings and strategy	Negative	-5.7%	Reported larger Q3 loss and cost cuts to focus on three late-stage programs.
Nov 04	Regulatory setback	Negative	-6.1%	Received FDA Complete Response Letter for VYGLXIA NDA in SCA.

Pattern Detected

Recent news skewed toward dilutive offerings and negative regulatory/earnings items, with most of those seeing share price declines, though two offering-related headlines saw positive divergences.

Recent Company History

Over the past six weeks, Biohaven reported a Complete Response Letter for troriluzole, a wider Q3 $173.4M GAAP net loss with a strategic refocus on late-stage assets, and a sequence of equity offerings raising roughly $200M. Despite generally negative events, some offering headlines produced positive price reactions. Today’s BHV-1510 Phase 1 data add encouraging oncology efficacy and safety signals alongside this capital-raising and pipeline-reprioritization backdrop.

Market Pulse Summary

The stock moved +7.9% in the session following this news. A strong positive reaction aligns with the clearly favorable BHV-1510 Phase 1 data, including ORR of 72.7% at the 2.5 mg/kg dose and a differentiated safety profile without interstitial lung disease. Historically, Biohaven’s clinical updates produced an average move of 4.43%, sometimes skewing negative on setbacks, so sustained strength would still need to contend with prior volatility and recent equity financings.

Key Terms

trop2 medical

"next-generation trophoblast cell surface antigen 2 (Trop2) directed antibody drug conjugate"

Trop2 is a protein found on the surface of many cancer cells that acts like a visible flag doctors and drugmakers can use to find and attack tumors. It matters to investors because drugs designed to bind Trop2 can deliver treatment directly to cancer cells, affecting how well a therapy works, which patients it helps, and the potential market and regulatory value of companies developing those targeted treatments.

antibody drug conjugate medical

"novel next-generation trophoblast cell surface antigen 2 (Trop2) directed antibody drug conjugate (ADC), BHV-1510"

An antibody drug conjugate is a targeted medical treatment that combines a special antibody with a powerful drug, allowing precise delivery of the medicine directly to cancer cells or other harmful cells in the body. For investors, it represents a sophisticated approach to therapy that could improve treatment effectiveness and reduce side effects, potentially leading to significant growth opportunities in the biotech and pharmaceutical sectors.

adc medical

"Trop2 directed antibody drug conjugate (ADC), BHV-1510, in combination with Regeneron's anti-PD-1 cemiplimab"

An antibody-drug conjugate (ADC) is a targeted cancer medicine that pairs an antibody that recognizes specific markers on tumor cells with a potent cell-killing drug, connected so the toxic payload is delivered directly to the cancer. For investors, ADCs matter because successful ADCs can improve patient outcomes and reduce side effects compared with traditional chemotherapy, shaping clinical trial success, regulatory approval chances, commercial demand, and a company’s valuation much like a guided missile versus a general bomb.

pd-1 medical

"Phase 1 study in combination with the anti-PD-1 cemiplimab"

PD-1 is a protein found on certain immune cells that acts like a brake, signaling the immune system to slow down and avoid damaging healthy tissue. Drugs that block PD-1 release that brake so immune cells can better attack cancer cells; because such therapies can produce large clinical benefits, regulatory approvals, trial outcomes, pricing and market uptake for PD-1 drugs can materially affect a drugmaker’s prospects and investor returns.

pd-l1 medical

"prior PD-(L)1 treatment, BHV-1510 2.5 mg/kg Q3W plus cemiplimab resulted in"

PD-L1 is a protein found on the surface of some cells that acts like a stop sign for the immune system, telling certain immune cells to back off. It matters to investors because many cancer drugs and diagnostic tests target or measure PD-L1 to unlock immune responses or predict which patients will benefit, affecting clinical success, regulatory approval, and potential sales in the oncology market.

interstitial lung disease medical

"there were no cases of interstitial lung disease, showing a differentiated safety profile"

A group of lung conditions that cause inflammation and scarring of the thin tissue between the air sacs, which makes it harder for oxygen to pass into the blood; imagine the lungs’ fine filters becoming stiff and less effective. Investors care because reports of interstitial lung disease can affect a drug’s safety profile, trigger regulatory warnings or label changes, and shift demand for treatments or create liability risks that influence a company’s valuation.

stomatitis medical

"only one participant had a dose limiting toxicity of stomatitis (Grade 3)"

Inflammation of the mouth lining, often causing soreness, ulcers, redness or swelling, like an irritating rash inside the mouth. Investors care because stomatitis can affect patient comfort and adherence in clinical trials and routine treatment, influence safety labeling, trigger additional healthcare costs or regulatory scrutiny, and therefore impact a therapy’s marketability and a healthcare company’s financial outlook.

pharmacokinetic medical

"The pharmacokinetic profile for BHV-1510 was favorable, the unconjugated payload"

Pharmacokinetic describes how a drug moves through and leaves the body — how it is absorbed, spread to tissues, broken down and excreted — like tracking a package from pickup to delivery and disposal. For investors, these properties determine effective dose, safety risks, how often a medicine must be taken, and how reliably it works, which in turn influence clinical trial success, regulatory approval chances, production complexity and a drug’s commercial value.

AI-generated analysis. Not financial advice.

• In a pretreated population of participants with advanced/metastatic cancer and the majority with prior PD-(L)1 treatment, BHV-1510 2.5 mg/kg Q3W plus cemiplimab resulted in confirmed objective response rates 3/5 (60%) in NSCLC, 4/4 (100%) in endometrial cancer, and 1/2 (50%) in urothelial cancer 
• There were low rates of adverse events attributed to unconjugated payload such as hematological toxicities and diarrhea, and there were no cases of interstitial lung disease, showing a differentiated safety profile of BHV-1510 from other Trop2 ADCs
• BHV-1510, a highly differentiated Trop2 ADC incorporating the proprietary TopoIx payload, demonstrates encouraging early clinical activity and favorable safety profile in a Phase 1 study in combination with the anti-PD-1 cemiplimab

LONDON and NEW HAVEN, Conn., Dec. 11, 2025 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN) announced today that it presented clinical safety and efficacy data for BHV-1510 at the 2025 European Society for Medical Oncology (ESMO) Immuno-Oncology Congress, taking place from December 10-12, 2025, in London, United Kingdom. The presentation highlights Biohaven's novel next-generation trophoblast cell surface antigen 2 (Trop2) directed antibody drug conjugate (ADC), BHV-1510, in combination with Regeneron's anti-PD-1 cemiplimab demonstrating efficacy and manageable safety across several tumors.

At the BHV-1510 dose of 2.5 mg/kg Q3W in combination with cemiplimab, confirmed ORR was 72.7%. Confirmed responses were observed in 3/5 (60%) in NSCLC, 4/4 (100%) in endometrial cancer, which included a complete response, and 1/2 (50%) in urothelial cancer (Fig.1). In all 23 efficacy evaluable participants treated with BHV-1510 in combination with cemiplimab across dose levels, as of the clinical cutoff date (October 10, 2025) the confirmed objective response rate (ORR) was 52.2%, with confirmed objective responses in 6/14 (42.9%) in NSCLC, 4/6 (66.7%) in endometrial cancer, and 1/2 (50%) in urothelial cancer (Fig. 2). A confirmed response was reported in the participant with triple negative breast cancer. The majority of participants had tumor reduction on their first scan, with a median time to response of 11.1 weeks. Participants remain on study at 6 months and beyond, 18 participants continue on the study treatment at time of the clinical cutoff date (Fig.3).

Ida Micaily, M.D., M.S., Principal Investigator and Assistant Professor at Sidney Kimmel Comprehensive Cancer Center at Jefferson stated, "We are excited by this emerging data and the potential synergy of BHV-1510 with cemiplimab. The early responses we are observing in these difficult-to-treat tumors—despite patients having received prior therapies, including other PD-1/PD-L1 agents—are particularly encouraging. We also have patients remaining on therapy beyond six months, suggesting the potential for durable disease control."

In the population studied, the median prior lines of therapy for advanced/metastatic disease were two and the majority (87.1%) had prior PD-(L)1 exposure with 16 participants (51.6%) receiving a PD-(L)1 as the most recent treatment prior to receiving study treatment. The maximum tolerated dose was not reached and only one participant had a dose limiting toxicity of stomatitis (Grade 3) at the 2.75 mg/kg Q3W dose. As of the clinical cutoff date, a total of 31 participants were treated with the combination of BHV-1510 and cemiplimab, with BHV-1510 doses ranging from 2-2.75 mg/kg Q3W and 1.25-1.5 mg/kg D1D8Q3W. Cemiplimab was given at 350 mg Q3W.

Across all doses BHV-1510, was generally well tolerated with a safety profile differentiated from other Trop-2 ADCs.  The rate of neutrophil count decrease was low and manageable; all Grade (Grade ≥3), 12.9% (6.5%). Similarly, the rates of treatment emergent diarrhea and alopecia were low; all Grade (Grade ≥3), 6.5% (0) and 9.7% respectively. The most frequent toxicity observed was oral mucositis/stomatitis all Grade (Grade ≥3), 59.1% (22.7%) in the Q3W regimen and all Grade (Grade ≥3), 33.3% (11.1%) in the D1D8Q3W regimen. This is a well-known class effect which is manageable. Importantly, there were no cases of interstitial lung disease, and no participants discontinued treatment due to an adverse event. Treatment emergent SAEs were reported in 4 participants, none of which were related to the study treatment. The pharmacokinetic profile for BHV-1510 was favorable, the unconjugated payload concentration was low with a payload-to-ADC molar ratio < 1%, indicating that ADC was highly stable in the circulation.

Nushmia Khokhar, M.D., Chief Medical Officer of Oncology at Biohaven, commented, "Continued preliminary clinical data with BHV-1510 in patients who have received and progressed on standard-of-care treatment, including prior anti-PD1/PDL1 therapy, are highly encouraging. These findings—together with the early promising efficacy, differentiated safety profile, lack of payload-related toxicity, enabled by our novel TopoIx payload and stable linker technology—underscores the potential for BHV-1510 to move into earlier lines of therapy, in particular with checkpoint inhibitor combinations, for these challenging tumor types."

Poster Presentation Information:

Poster 252P: Phase 1 clinical trial of BHV-1510, a next generation Trop2 ADC, in combination with the PD-1 monoclonal antibody, cemiplimab in patients with advanced solid tumors.
Date/Time: Wednesday, December 10, 2025, 5:15-6:30 pm GMT

The poster will be available on the Posters and Presentations page after the conference at www.biohaven.com.   

About Biohaven 
Biohaven is a biopharmaceutical company focused on the discovery, development and commercialization of life-changing treatments in key therapeutic areas, including immunology, neuroscience and oncology. Biohaven is advancing its innovative portfolio of therapeutics, leveraging its proven drug development experience and multiple proprietary drug development platforms. Biohaven's key clinical and preclinical programs include Kv7 ion channel modulation for epilepsy and mood disorders; MoDE™ and TRAP™ extracellular protein degradation for immunological diseases; and myostatin-activin pathway targeting agent for neuromuscular and metabolic diseases, including SMA and obesity. For more information, visit www.biohaven.com.

Forward-looking Statements
This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The use of certain words, including "continue", "plan", "will", "believe", "may", "expect", "potential first-in-class", "potentially", "groundbreaking" and similar expressions, is intended to identify forward-looking statements. Investors are cautioned that any forward-looking statements, including statements regarding the future development, timing and potential marketing approval and commercialization of development candidates, are not guarantees of future performance or results and involve substantial risks and uncertainties. Actual results, developments and events may differ materially from those in the forward-looking statements as a result of various factors including: the expected timing, commencement and outcomes of Biohaven's planned and ongoing clinical trials, including the studies of BHV-1510; the timing of planned interactions and filings with the FDA; the timing and outcome of expected regulatory filings; complying with applicable US regulatory requirements; the potential commercialization of Biohaven's product candidates; and the effectiveness and safety of Biohaven's product candidates. Additional important factors to be considered in connection with forward-looking statements are described in Biohaven's filings with the Securities and Exchange Commission, including within the sections titled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations". The forward-looking statements are made as of the date of this news release, and Biohaven does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

MoDE and TRAP are trademarks of Biohaven Therapeutics Ltd.

Investor Contact:
Jennifer Porcelli
Vice President, Investor Relations
jennifer.porcelli@biohavenpharma.com
+1 (201) 248-0741

Media Contact:
Mike Beyer
Sam Brown Inc.
mikebeyer@sambrown.com
+1 (312) 961-2502

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SOURCE Biohaven Ltd.

FAQ

What were the confirmed ORR results for BHV‑1510 plus cemiplimab reported Dec 11, 2025 (BHVN)?

At the 2.5 mg/kg Q3W dose confirmed ORR was 72.7%; across 23 efficacy‑evaluable participants confirmed ORR was 52.2%.

Which tumor types showed responses to BHV‑1510 plus cemiplimab in the Phase 1 data?

Confirmed responses were observed in NSCLC, endometrial cancer (4/4, including a CR), urothelial cancer, and a reported response in one triple negative breast cancer participant.

What safety findings did Biohaven report for BHV‑1510 with cemiplimab at ESMO 2025?

Low rates of payload‑related toxicities, no interstitial lung disease, no treatment discontinuations for AEs, but oral mucositis/stomatitis was common (Q3W all‑grade 59.1%, Grade ≥3 22.7%).

How many patients were treated and what was the study cutoff for Biohaven's BHV‑1510 data (BHVN)?

As of the clinical cutoff date Oct 10, 2025, 31 participants were treated with BHV‑1510 plus cemiplimab; 23 were efficacy‑evaluable.

Did Biohaven report any pharmacokinetic or payload stability data for BHV‑1510?

Yes — pharmacokinetics were described as favorable with unconjugated payload concentration low and a payload‑to‑ADC molar ratio <1%, indicating high circulation stability.