Genmab A/S (GMAB) News & EventsGMABGenmab A/S

Incyte and Genmab Collaborate to Evaluate INCB161734 Clinical Trial

Incyte (INCY) and Genmab A/S (GMAB) announced a clinical trial collaboration to evaluate INCB161734, Incyte's investigational, potent and selective KRAS G12D inhibitor, in combination with petosemtamab, Genmab's investigational IgG1-bispecific antibody targeting the epidermal growth factor receptor and leucine-rich repeat containing G-protein-coupled receptor 5, and standard-of-care chemotherapy as a first-line treatment for patients with metastatic colorectal cancer harboring KRAS G12D mutation, an area with substantial unmet medical need. Under the collaboration, Genmab will conduct the Phase 1/2 study evaluating INCB161734 in combination with petosemtamab and standard-of-care chemotherapy in patients with KRAS G12D-mutated mCRC in the first-line setting. Incyte will co-fund the study and provide clinical supply of INCB161734.

Genmab Updates Petosemtamab Trial Data

Genmab announced updated follow-up analyses from a Phase 2 trial evaluating petosemtamab, an investigational IgG1-bispecific antibody targeting the epidermal growth factor receptor, EGFR, and leucine-rich repeat containing G-protein-coupled receptor 5, in combination with FOLFOX or FOLFIRI in patients with metastatic colorectal cancer, mCRC. At a median follow-up of 5.9 months in the first-line setting and 7.1 months in the second-line setting, confirmed and unconfirmed objective response rates, ORRs, were 75% and 67%, respectively, with an ORR of 81% observed among 1L patients with left-sided tumors. With longer follow-up, most of the previously unconfirmed objective responses were subsequently confirmed, reinforcing the consistency of the clinical activity observed across treatment settings. The updated analyses reinforce the depth and durability of responses observed in both 1L and 2L treatment settings and support the ongoing global Phase 3 development program. The findings were presented at the European Society for Medical Oncology, ESMO, Congress 2026, held in Madrid, Spain.

Genmab's Rina-S Phase 3 Trial Shows Positive Results

Genmab announced positive topline results from the global Phase 3 RAINFOL-02 trial of rinatabart sesutecan, an investigational folate receptor alpha-targeted, topoisomerase I-inhibitor antibody-drug conjugate, in patients with platinum-resistant ovarian cancer regardless of FRalpha expression level or prior treatment with mirvetuximab. The trial met its primary endpoint of progression-free survival, with Rina-S demonstrating a statistically significant and clinically meaningful improvement compared with investigator's choice chemotherapy in the intent-to-treat and in the primary analysis set populations. The ITT population comprised of all randomized patients with PROC, regardless of FRalpha expression. The PAS population mandated patients with FRalpha expression greater than or equal to75% PS2+ to have been treated with mirvetuximab. In the ITT population, Rina-S demonstrated a 71% reduction in the risk of disease progression or death. In the PAS population, Rina-S demonstrated a 67% reduction in the risk of disease progression or death. The study also met its key secondary endpoint of overall survival, demonstrating a statically significant and clinically meaningful improvement in the ITT population and in the PAS population. The observed safety profile was consistent with the known profile of Rina-S, with no new safety signals or unexpected safety concerns identified. "As the first Phase 3 readout from our Rina-S program, the positive topline results from RAINFOL-02 mark a significant milestone for Genmab and strengthen our confidence in Rina-S's potential for patients with platinum-resistant ovarian cancer. These results advance our ambition to become a leader in gynecologic oncology and reflect our commitment to improving the lives of patients with high unmet medical needs," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "We look forward to discussing these results and potential next steps with regulatory authorities worldwide. We are deeply grateful to the patients, caregivers, and investigators whose participation made this study possible." Based on these results, Genmab plans to engage with regulatory authorities worldwide regarding potential next steps. The data will also be submitted for presentation at a future medical meeting.