Industry News: AbbVie's Bispecific Antibody Hits Dual Primary Endpoints in Phase 3; GLP-1 Therapy Licensed for Up to €726M; HUTCHMED Inks $1.295B Deal with GSK

AbbVie's Bispecific Antibody Hits Dual Primary Endpoints in Phase 3 Trial; GLP-1 Therapy Licensed for Up to €726 Million

Phase 3 Trial Achieves Dual Primary Endpoints: AbbVie's Bispecific Antibody Delivers Positive Topline Results

AbbVie announced today that etentamig, its investigational bispecific T-cell engager targeting B-cell maturation antigen (BCMA) and CD3, achieved positive topline results in the Phase 3 CERVINO study for relapsed/refractory multiple myeloma (RRMM).

The study met both primary endpoints: objective response rate (ORR) and progression-free survival (PFS). At a median follow-up of 11.4 months, the etentamig arm achieved an ORR of 74.0%, while the risk of disease progression or death was reduced by 60% compared to the investigator's choice of standard available therapy (HR=0.40; 95% CI: 0.29–0.54; p<0.0001).

The CERVINO study enrolled 393 patients who had received a median of 3 prior lines of therapy. In the overall survival (OS) analysis, the 12-month OS rate was 87.9% in the etentamig arm versus 72.0% in the investigator's choice arm (HR=0.48; 95% CI: 0.29–0.77). As of the data cutoff, OS had not yet reached the prespecified efficacy boundary. Based on these interim analysis results, the independent data monitoring committee recommended unblinding the study. AbbVie plans to discuss next steps for development and regulatory pathways with global regulatory authorities.

Regarding safety, etentamig is administered once every four weeks following an initial dose escalation. Among patients receiving this regimen, the incidence of cytokine release syndrome (CRS) was 28.3%, with most cases being Grade 1; no Grade 3 or higher CRS events were reported. The incidence of immune effector cell-associated neurotoxicity syndrome (ICANS) was 0.9%, with only one Grade 1 event reported.

Etentamig is an investigational second-generation BCMA/CD3 bispecific antibody T-cell engager that works by simultaneously binding BCMA on multiple myeloma cells and CD3 on T cells, promoting T-cell targeting of tumor cells.

Up to €726 Million: Biweekly GLP-1 Therapy Reaches Licensing Agreement

Gan & Lee Pharmaceuticals and Menarini Group announced today an exclusive licensing agreement to jointly advance the registration and commercialization of bofanglutide (GZR18), a long-acting glucagon-like peptide-1 receptor agonist (GLP-1 RA). The therapy is being developed for adult obesity or overweight management, administered via subcutaneous injection once every two weeks.

Under the agreement, Gan & Lee will receive an upfront payment of €62 million and is eligible for up to €664 million in development and commercialization milestone payments, bringing the total potential deal value to €726 million. Menarini will be responsible for regulatory submissions and commercialization within the licensed territory.

Bofanglutide is an investigational long-acting GLP-1 receptor agonist. According to the press release, its pivotal Phase 3 and Phase 2 studies for adult obesity or overweight weight management have both met primary endpoints, demonstrating weight loss efficacy with a tolerability profile consistent with the GLP-1 receptor agonist class overall.

Gan & Lee is currently advancing the global development program for bofanglutide and plans to initiate a global Phase 3 clinical development project to support registration of the therapy in Europe and other markets.

Up to $1.295 Billion: GSK Licenses KRAS-EGFR Antibody-Targeted Conjugate

HUTCHMED announced today that its subsidiary Hutchison MediPharma (Shanghai) Co., Ltd. has entered into an exclusive development and licensing agreement with a GSK subsidiary, granting the latter rights to develop and commercialize HMPL-A830 worldwide, excluding mainland China, Hong Kong, Macau, and Taiwan. Clinical development will initially focus on colorectal cancer, pancreatic cancer, and lung cancer indications.

Under the agreement, HUTCHMED will receive an upfront payment of $110 million and is eligible for up to $1.185 billion in potential development, regulatory, and commercialization milestone payments, bringing the total deal value to up to $1.295 billion. HUTCHMED will retain full development and commercialization rights for HMPL-A830 in mainland China, Hong Kong, Macau, and Taiwan.

HMPL-A830 is an investigational KRAS-EGFR antibody-targeted conjugate (ATTC), composed of a highly selective, highly active KRAS small molecule inhibitor as the payload, conjugated to an anti-epidermal growth factor receptor (EGFR) antibody.

The ATTC platform uses antibody guidance to enable the potent payload to selectively concentrate in tumor tissue and exert its activity. HMPL-A830 is designed to deliver KRAS inhibitors directly to EGFR-expressing tumors while blocking both EGFR and KRAS signaling pathways, with the aim of enhancing efficacy, durability, and tolerability. HUTCHMED will be responsible for the global Phase 1 clinical development program for HMPL-A830, which is expected to commence in the second half of 2026; thereafter, the GSK subsidiary will be responsible for subsequent clinical development and commercialization activities within the licensed territory.

References:
[1] AbbVie Announces Positive Topline Results from the Phase 3 CERVINO Trial Showing Etentamig Significantly Improved Response Rate and Progression-Free Survival in Patients with Relapsed/Refractory Multiple Myeloma. Retrieved September 3, 2026, from https://news.abbvie.com/2026-09-03-AbbVie-Announces-Positive-Topline-Results-from-the-Phase-3-CERVINO-Trial-Showing-Etentamig-Significantly-Improved-Response-Rate-and-Progression-Free-Survival-in-Patients-with-Relapsed-Refractory-Multiple-Myeloma
[2] Gan & Lee and Menarini Group Partner to Advance Bofanglutide in Europe. Retrieved September 3, 2026, from https://www.prnewswire.com/news-releases/gan--lee-and-menarini-group-partner-to-advance-bofanglutide-in-europe-302868846.html
[3] HUTCHMED Announces Licensing Agreement with GSK for KRAS-EGFR Antibody-Conjugated Cancer Drug. Retrieved September 3, 2026, from https://www.hutch-med.com/sc/hutchmed-gsk-licensing-agreement-kras-egfr-attc/

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