MacroGenics Reports Encouraging Interim Phase 2 LINNET Data for Lorigerlimab in Clear Cell Gynecologic Cancer

2026-10-26

Investivoq

Lorigerlimab shows 25% response rate and manageable safety in advanced clear cell gynecologic cancer; further studies planned.

Investivoq AI Summary

MacroGenics, Inc. announced promising preliminary results from its Phase 2 LINNET study of lorigerlimab, a bispecific antibody targeting PD-1 and CTLA-4, in patients with clear cell gynecologic cancers (CCGC). The study reported a confirmed objective response rate (ORR) of 25% and a disease control rate (DCR) of 44% among 41 patients treated. The safety profile was considered manageable, though 49% experienced grade ≥3 treatment-related adverse events. As part of ongoing research, MacroGenics is exploring lower dosing and plans to report further findings in the first half of 2027. These results highlight lorigerlimab's potential as a new treatment option for this aggressive and treatment-resistant cancer type.

Potential Positives

Single agent lorigerlimab demonstrated a confirmed objective response rate (ORR) of 25% and a disease control rate (DCR) of 44% in patients with clear cell gynecologic cancer, indicating promising preliminary clinical activity.
The manageable safety profile, with a focus on ongoing dose optimization, suggests the potential for lorigerlimab to be a viable treatment option for patients with aggressive gynecologic cancers.
The upcoming sharing of updated LINNET results in the first half of 2027 highlights the company's commitment to transparency and ongoing research, which may bolster investor confidence and interest.

Potential Negatives

Confirmed objective response rate (ORR) of only 25% in CCGC patients may raise concerns about the overall efficacy of lorigerlimab compared to existing treatment options.
Nearly half (49%) of patients experienced grade ≥3 treatment-related adverse events (TRAEs), indicating a potentially high level of severe side effects, which might deter patient enrollment and acceptance.
One Grade 5 TRAE in the PROC cohort highlights the severity of potential risks associated with lorigerlimab treatment.

FAQ

What is lorigerlimab and its role in gynecologic cancer treatment?

Lorigerlimab is a bispecific DART molecule targeting PD-1 and CTLA-4, showing promise in treating clear cell gynecologic cancers.

What were the results of the Phase 2 LINNET study?

The study reported a 25% objective response rate and a 44% disease control rate in clear cell gynecologic cancer patients.

How does the safety profile of lorigerlimab compare to other treatments?

Lorigerlimab demonstrated a manageable safety profile, consistent with dual PD-1/CTLA-4 blockade, with 49% experiencing grade ≥3 treatment-related adverse events.

When will updated results from the LINNET study be available?

MacroGenics anticipates sharing updated LINNET study results in the first half of 2027.

What is the mechanism of action for lorigerlimab?

Lorigerlimab is designed to enhance the blockade of PD-1 and CTLA-4 on tumor-infiltrating lymphocytes, improving cancer treatment outcomes.

Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.

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Full Release

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.