MacroGenics Announces Positive Interim Phase 2 LINNET Results for Lorigerlimab in Advanced Clear Cell Gynecologic Cancer

Further dose optimization is being pursued with a lower lorigerlimab dose of 3 mg/kg every three weeks.

Rhea-AI Summary

MacroGenics (NASDAQ: MGNX) reported interim Phase 2 lorigerlimab results showing a 25% response rate in clear cell gynecologic cancer (CCGC).

At the September 1, 2026 cutoff, confirmed responses occurred in 4 of 16 response-evaluable CCGC patients; disease control was 44% (7/16). All responses remained ongoing. Among 17 safety-evaluable CCGC patients, median progression-free survival was 2.9 months (95% confidence interval, 1.9–6.2), with 33% progression-free at six months.

The LINNET study treated 41 patients at 6 mg/kg every three weeks, including 24 with platinum-resistant ovarian cancer. Grade 3 or higher treatment-related adverse events occurred in 49%, with one Grade 5 (fatal) event in the ovarian cancer cohort. Treatment-related events caused discontinuation in 24% overall and 18% of CCGC patients. MacroGenics is enrolling 20 additional CCGC patients at 3 mg/kg every three weeks and expects updated results in the first half of 2027.

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Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate pointConfirmed response rate reached 25% (4/16) in response-evaluable CCGC patients; all responses remained ongoing at cutoff.
• Minor pointDisease control rate was 44% (7/16) in response-evaluable CCGC patients.
• Minor pointLower-dose enrollment is underway for 20 additional CCGC patients at 3 mg/kg every three weeks.
• Minor point. Forward-looking: it has not happened yet and may not happen.Updated LINNET results are expected in the first half of 2027.

Negative

• Moderate pointGrade 3 or higher treatment-related adverse events occurred in 49% of all 41 patients.
• Minor pointOne Grade 5 (fatal) treatment-related adverse event occurred in the platinum-resistant ovarian cancer cohort.
• Minor pointTreatment-related events caused discontinuation in 24% overall and 18% of CCGC patients.
• Minor pointCommon Grade 3 or higher treatment-related events included anemia 10%, decreased neutrophils 10%, elevated aspartate aminotransferase 7%.
• Minor pointEfficacy findings remain preliminary in the ongoing Phase 2 LINNET study.

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Market Reaction – MGNX

$2.21 – $2.52 Day Range

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On Oct 26, the day this news came out, the latest delayed price for MGNX is 0.44% above the previous close. The latest delayed price is $2.26. Relative volume is exceptionally heavy at 74.6x the average.

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Key Figures

Confirmed objective response rate: 25% (4/16) Disease control rate: 44% (7/16) Grade ≥3 treatment-related adverse events: 49% +5 more

Confirmed objective response rate

25% (4/16)

Response-evaluable CCGC patients

Disease control rate

44% (7/16)

Response-evaluable CCGC patients

Grade ≥3 treatment-related adverse events

49%

All patients

Grade 5 treatment-related adverse events

1

PROC cohort

Treatment-related discontinuation

18%

CCGC patients

Median progression-free survival

2.9 months (95% CI, 1.9–6.2)

Safety-evaluable CCGC patients

Six-month progression-free survival rate

33%

CCGC patients

Additional CCGC enrollment

20 patients at 3 mg/kg Q3W

Ongoing LINNET study

Key Terms

objective response rate, disease control rate, progression-free survival, treatment-related adverse events, +1 more

5 terms

objective response rate medical

"the confirmed objective response rate (ORR) was 25% (4/16)"

The objective response rate (ORR) is the percentage of patients in a clinical trial whose tumors measurably shrink or disappear according to preset rules. Investors use it as a quick, objective signal of a drug’s ability to produce a clear treatment effect—like counting how many plants visibly respond after applying a new fertilizer—and higher ORR can improve odds of regulatory approval, commercial success, and company valuation.

disease control rate medical

"the disease control rate was 44% (7/16)"

The disease control rate is the share of patients in a clinical trial whose cancer or condition either shrinks or stops getting worse for a specified period after treatment. Think of it like the percentage of people for whom a treatment hits pause or nudges back the problem rather than letting it progress; higher rates suggest the therapy can meaningfully limit disease, which matters to investors assessing a drug’s potential efficacy and commercial value.

progression-free survival medical

"the median progression-free survival (PFS) was 2.9 months"

Progression-free survival is the length of time during and after a treatment that a patient's disease does not get worse, measured from the start of treatment until the disease shows measurable signs of progression or the patient dies. Investors care because longer progression-free survival in clinical trials often signals that a drug is effective, improving chances of regulatory approval, market adoption, and revenue potential—think of it as a stopwatch showing how long a therapy can keep the illness at bay.

treatment-related adverse events medical

"Grade ≥3 treatment-related adverse events (TRAEs) occurred in 49%"

Treatment-related adverse events are harmful or unwanted health effects that doctors or regulators determine were caused by a drug, vaccine, device, or other medical therapy. Investors care because how often and how severe these side effects are can shape regulatory approval, labeling, sales potential and legal risk — similar to how product defects can stop or damage a company's ability to sell an item.

bispecific medical

"a bispecific DART® molecule that targets PD-1 and CTLA-4"

A bispecific molecule is a therapeutic designed to bind two different biological targets at once — imagine a two-headed key that fits two locks simultaneously. For investors, bispecific therapies matter because that dual-action can make a treatment more effective or selective, potentially improving clinical results, altering safety profiles, and creating a stronger commercial edge; those factors directly affect development risk, regulatory chances, and future revenue prospects.

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• Single agent lorigerlimab demonstrated encouraging preliminary clinical activity in clear cell gynecologic cancer (CCGC) with a confirmed ORR of 25% and a DCR of 44%
• Safety profile was manageable; further dose optimization being pursued with lower dose of 3 mg/kg Q3W
• Anticipate sharing updated LINNET results in first half of 2027

ROCKVILLE, MD, Oct. 26, 2026 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on developing innovative antibody-based therapeutics for the treatment of cancer, today announced positive interim data from its ongoing Phase 2 LINNET study evaluating lorigerlimab, a bispecific DART® molecule that targets PD-1 and CTLA-4, in patients with CCGC. These Phase 2 data were presented today at the European Society for Medical Oncology (ESMO) 2026 Congress in Madrid, Spain. 

“Clear cell gynecologic malignancies are notoriously aggressive, resistant to conventional platinum-based chemotherapies, and carry a poor prognosis. New targeted treatments are urgently needed,” said Amir Jazaeri, M.D., Professor and Vice Chair for Clinical Research in the Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, and lead author of the poster. “The 25% response rate and manageable tolerability profile in CCGC observed in the LINNET study represent a highly encouraging potential therapeutic signal for a single agent in this difficult-to-treat histological subtype.”

Encouraging Activity and Manageable Safety Profile

As of the data cutoff of September 1, 2026, 41 patients with advanced gynecologic cancers, including high-grade serous epithelial platinum-resistant ovarian cancer (PROC) (n=24) and CCGC (n=17), including ovarian, endometrial, vaginal, vulval, or cervical cancer, had been treated with lorigerlimab administered intravenously every three weeks (Q3W) at 6 mg/kg. The PROC study participants had received a median of two prior lines of therapy (range 1-3) and the CCGC patients had received a median of one prior line of therapy (range 1-3).

All 41 patients were evaluable for safety. In these patients, lorigerlimab demonstrated a manageable safety profile that was consistent with dual PD-1/CTLA-4 blockade. Grade ≥3 treatment-related adverse events (TRAEs) occurred in 49% of patients, with the most common events (observed in ≥5% of participants) being anemia (10%), neutrophil count decreased (10%) and aspartate aminotransferase increased (7%). There was one Grade 5 TRAE in the PROC Cohort. TRAEs led to discontinuation of lorigerlimab in 24% of all patients (18% in CCGC patients).

Among 16 response-evaluable patients with CCGC, the confirmed objective response rate (ORR) was 25% (4/16), and the disease control rate was 44% (7/16). All responses remained ongoing at data cutoff. In the 17 safety-evaluable patients with CCGC, the median progression-free survival (PFS) was 2.9 months (95% CI, 1.9-6.2) and PFS rate at 6 months was 33%.

MacroGenics is enrolling 20 additional CCGC patients at a dose of 3 mg/kg Q3W and the Company anticipates reporting updated study results in the first half of 2027.

“We are encouraged by the efficacy and manageable safety profile demonstrated in the Phase 2 LINNET study to date and these results mark an important milestone for lorigerlimab and highlight its potential for treating patients facing clear cell gynecologic cancers,” said Eric Risser, President and Chief Executive Officer of MacroGenics. “We believe these data support the promise of dual PD-1/CTLA-4 blockade and lorigerlimab’s potential to improve the treatment paradigm for this underserved patient population.”

Poster Presentation Details

Title: LINNET: A Phase 2 Study to Evaluate Lorigerlimab in Participants With Advanced Gynecologic Cancers
Lead author: Amir A. Jazaeri, M.D.
Session: Gynaecological Cancers
Poster number: 1278P
Date and time: Monday, October 26, 2026, from 12:00 to 12:45 PM CEST

A copy of the above ESMO poster presentation is available on the Company's Investor Relations website through this direct link: ESMO poster presentation.

About the Phase 2 LINNET Study

The Phase 2 LINNET study was designed to evaluate single-agent lorigerlimab in PROC and CCGC patients who had received one or more prior lines of systemic therapy. The study’s primary endpoint is ORR, with multiple secondary endpoints. As of the September 1, 2026 data cutoff, 42 study participants had been dosed in this study, and more than 300 study participants had been dosed across all previous lorigerlimab Phase 1 and Phase 2 clinical trials. Additional information about the study is available at www.clinicaltrials.gov using the identifier NCT06730347.

About Lorigerlimab

Lorigerlimab (previously known as MGD019) is an investigational, tetravalent bispecific IgG4-based, Fc-bearing DART molecule that was designed to enhance blockade on PD-1 and CTLA-4 dual-expressing, tumor-infiltrating lymphocytes, while maintaining maximal PD-1 blockade on all circulating PD-1-expressing cells.

About MacroGenics, Inc.

MacroGenics (the Company) is a biopharmaceutical company focused on developing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics’ technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company’s website at www.macrogenics.com. MacroGenics, the MacroGenics logo and DART® are trademarks or registered trademarks of MacroGenics, Inc.

Cautionary Note on Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for MacroGenics (“Company”), including statements about the Company’s strategy, future operations, clinical development of and regulatory plans for the Company’s therapeutic candidates, expected timing of the release of clinical updates and safety and efficacy data for the Company’s ongoing clinical trials, anticipated cash runway and other statements containing the words “subject to”, "believe", “anticipate”, “plan”, “expect”, “intend”, “estimate”, “potential”, “project”, “may”, “will”, “should”, “would”, “could”, “can”, the negatives thereof, variations thereon and similar expressions, or by discussions of strategy, including our ability to execute on our key strategic priorities for 2026, constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: risks related to the reproducibility of any results initially seen in any product candidate including the results for lorigerlimab discussed herein; risks that any product candidate’s revenue, expenses and costs may not be as expected; risks relating to any other product candidate’s market acceptance, competition, reimbursement and regulatory actions; future data updates for lorigerlimab any other product candidates, including timing and results of efficacy and safety data with respect to lorigerlimab any other product candidates in ongoing clinical trials; the uncertainties inherent in the initiation and enrollment of future clinical trials; the availability of financing to fund the internal development of our product candidates; expectations regarding the expansion of ongoing clinical trials; expectations for the timing and steps required in the regulatory review process; expectations for regulatory approvals; expectations of future milestone payments; the impact of competitive products; our ability to enter into agreements with strategic partners and other matters that could affect the availability or commercial potential of the Company's product candidates; business, economic or political disruptions due to catastrophes or other events, including natural disasters, terrorist attacks, civil unrest and actual or threatened armed conflict, or public health crises; costs of litigation and the failure to successfully defend lawsuits and other claims against us; risks related to the transition of the CDMO operations to the purchaser following the sale of our CDMO operations; and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.

CONTACTS
Jim Karrels, Senior Vice President, CFO
1-301-251-5172
info@macrogenics.com

Argot Partners
1-212-600-1902
macrogenics@argotpartners.com

FAQ

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What did MacroGenics' Phase 2 LINNET trial show in clear cell gynecologic cancer?

Lorigerlimab produced a confirmed response rate of 25% (4/16) and a disease control rate of 44% (7/16) among response-evaluable CCGC patients. All responses remained ongoing at the September 1, 2026 cutoff. Among 17 safety-evaluable CCGC patients, median progression-free survival was 2.9 months, and the six-month progression-free survival rate was 33%.

What safety results did MacroGenics report for lorigerlimab in LINNET?

Grade 3 or higher treatment-related adverse events occurred in 49% of the 41 safety-evaluable patients receiving 6 mg/kg every three weeks. One Grade 5 (fatal) treatment-related event occurred in the platinum-resistant ovarian cancer cohort. Treatment-related events led to discontinuation in 24% overall and 18% of CCGC patients.