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BioSpace·3h ago·3 min read
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Genmab’s cancer bispecific delivers early survival win in ‘exceedingly positive’ Phase 3 readout

Analysts hailed the Phase 3 head and neck cancer results as a big victory for an asset central to Genmab’s growth plans.

Oct 28, 2026·read at BioSpace ↗

News Drug Development Genmab’s cancer bispecific delivers early survival win in ‘exceedingly positive’ Phase 3 readout October 28, 2026 | 2 min read | Nick Paul Taylor Twitter LinkedIn Facebook Email Print Analysts hailed the Phase 3 head and neck cancer results as a big victory for an asset central to Genmab’s growth plans. A late-stage trial of Genmab’s petosemtamab hit its co-primary endpoints at the first interim analysis, the biotech said Wednesday, completing a clean sweep of victories in a high-stakes run of readouts.The LiGeR-HN1 study tested petosemtamab, a bispecific antibody targeting EGFR and LGR5, in combination with Merck’s Keytruda in nearly 700 patients with PD-L1-positive head and neck squamous cell carcinoma (HNSCC). Given as a first-line treatment, the combination significantly improved overall survival (OS) and objective response rate (ORR) compared to single-agent Keytruda, meeting its co-primary endpoints.The investigational combination reduced the risk of death by 50%, regardless of HPV status.

William Blair analysts in a Wednesday morning note called the result “exceedingly positive,” while their counterparts at Truist Securities hailed the OS finding as “highly compelling and potentially practice-changing.”Genmab has now delivered positive data on three key candidates in quick succession. At the start of October, the biotech was preparing to share Phase 3 data on its AbbVie-partnered bispecific antibody Epkinly, the antibody-drug conjugate rinatabart sesutecan (Rina-S) and petosemtamab. Weeks later, Genmab has positive data from all three studies.Genmab’s stock rose 29% to $57.57 in early trading on Wednesday.

Pipeline Epkinly data only one of Genmab’s make-or-break readouts ahead of steep sales erosion Bracing for patent losses on its cornerstone product Darzalex, Genmab has bet its future on three cancer programs that will deliver pivotal readouts in quick succession. October 20, 2026 · 5 min read · Nick Paul Taylor Read more “We view the Rina-S and peto OS wins as particularly striking and believe all three franchises can support multibillion-dollar opportunities,” Truist analysts said. “Full data remain important given the first interim analysis, and we look for additional color on OS maturity, absolute ORR, safety and regulatory timing.” Genmab has yet to disclose the median OS or ORR.

Based on Keytruda’s historical performance in the setting, Truist analysts estimate that the petosemtamab combination may have achieved a median OS of about 30 months, broadly in line with the 28.2-month result seen in Phase 2. The analysts forecast that the ORR result could be in the 44% to 58% range.The earlier-than-expected interim OS hit could accelerate Genmab’s path to market, Truist said. Analysts had initially expected OS results in 2027.

The OS success suggests “a particularly strong treatment effect” and supports potential approval in 2027, Truist said—ahead of the 2028 approval currently modeled by Truist. Bringing petosemtamab to market earlier than expected would give Genmab more time to grow sales of the product before the expiration of patents on Darzalex, its Johnson and Johnson-partnered multiple myeloma drug.Preparing for the patent loss, Genmab invested in Epkinly, an internally discovered program, and struck deals for petosemtamab and Rina-S. Petosemtamab represented the biggest bet, with Genmab acquiring the drug candidate in its $8 billion takeover of Merus in September 2025.

Mergers & acquisitions Genmab Buys Rising Cancer Star Merus for $8B The centerpiece of the acquisition is petosemtamab, Merus’ bispecific antibody targeting EGFR and LGR5, which in May demonstrated best-in-class potential for head-and-neck cancer. September 29, 2025 · 2 min read · Tristan Manalac Read more Bicara Therapeutics’ ficerafusp alfa is a potential competitor to petosemtamab, with the biotech on track to report interim Phase 3 HNSCC data in mid-2027. Shares in Bicara, which is only enrolling HPV-negative patients in its HNSCC trial, were down 48% to $8.94 as of publication.BMO Capital Markets took a more positive stance on Bicara, however, saying in a Wednesday morning note that “on first blush,” the stock weakness doesn’t match the outlook for the company.

The early OS result for Genmab “increases our confidence in ficerafusp delivering OS success at its mid-2027 Ph3 interim,” the analysts said. Twitter LinkedIn Facebook Email Print Cancer Phase 3 Nick Paul Taylor Nick is a freelance writer who has been reporting on the global life sciences industry since 2008.

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Reporting by BioSpace.

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companies & drugs in this story

companies
ABBVIEBicara Therapeutics Inc.PATHRISING
drugs
petosemtamab9Cancer Program3EPKINLY3HNSCC3KEYTRUDA3epcoritamab3pembrolizumab3daratumumab2daratumumab + Gene Therapy2ficerafusp alfaicosapent ethylrinatabart sesutecan
topics
Oncology8Bispecific Antibody5Monoclonal Antibody4Approval2EGFR2Phase 3 Readout2Multiple MyelomaPD-L1

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