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Genmab Announces Updated Follow-Up Analyses from Phase 2 Study of Petosemtamab Demonstrate Meaningful Objective Response Rates in Patients with Metastatic Colorectal Cancer

Business Wire

  • Petosemtamab demonstrates encouraging objective response rates (ORRs), with promising depth and durability of response, in first- and second-line metastatic colorectal cancer (mCRC)

  • Data reinforces the ongoing global Phase 3 trials of petosemtamab in mCRC, which are actively enrolling patients

COPENHAGEN, Denmark, October 25, 2026--Genmab A/S (Nasdaq: GMAB) today 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 (LGR5), 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 (1L) setting and 7.1 months in the second-line (2L) 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.

"Despite advances in the treatment of metastatic colorectal cancer, outcomes remain poor for many patients once disease has spread, including those with RAS/BRAF wild-type disease who may face limited options after standard chemotherapy and targeted therapy," said Ruth Vera, M.D., Medical Oncology Department, Hospital Universitario de Navarra, and study investigator. "The encouraging response rates observed in both the first- and second-line settings, along with the maturation of the dataset over time, suggest that treatment with petosemtamab plus chemotherapy may offer a potential new approach for these patients."

As of May 15, 2026, 79 patients were treated with the petosemtamab combination, including 45 patients in the 1L setting and 34 patients in the 2L setting. Among efficacy-evaluable patients, confirmed and unconfirmed ORR was 75% in 1L patients and 67% in 2L patients. In 1L patients with left-sided tumors, ORR was 81%. Responses were observed across key patient subgroups, including patients with liver metastases, which is a poor prognostic factor in mCRC, with ORRs of 76% and 67% in the 1L and 2L settings, respectively. Median follow-up was 5.9 months in the 1L setting and 7.1 months in the 2L setting, with 76% and 74% of patients, respectively, remaining on treatment at the data cutoff. Disease control rate was 95% in 1L patients and 93% in 2L patients.

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