Genmab's Petosemtamab Expands into Colorectal Cancer as Readout Calendar Denseens
A Beat-and-Raise Quarter
Genmab's first half of 2026 delivered on its promise of accelerating late-stage pipeline progress while disciplined capital allocation remains intact. “We grew total revenue by 25% driven by continued momentum across our portfolio.” — Jan van de Winkel, Chief Executive Officer · 2026-08-06 The growth was broad-based: DARZALEX rose 21%, EPKINLY net product sales jumped 48%, and the remainder of the portfolio climbed 35%. The company raised its 2026 revenue guidance by 5% and operating profit by 7% at the midpoint, reflecting the strength and flexibility of the business. “The majority of our revenue outperformance continues to translate into higher operating profit while preserving our ability to invest behind our highest value growth opportunities.” — Anthony Pagano, Chief Financial Officer · 2026-08-06
This quarter also marked a strategic expansion for petosemtamab—the company initiated two new Phase III trials in colorectal cancer, a key step in broadening the asset beyond head and neck. The decision, highlighted by Tahamtan Ahmadi, is based on compelling early clinical data and the unique mechanism that targets both EGFR and LGR5. “The rationale for its development in metastatic colorectal cancer is compelling. EGFR antibodies are approved as standard of care. And LGR 5 is a marker of cancer stem cells.” — Tahamtan Ahmadi, Chief Medical Officer · 2026-08-06 The company also confirmed updated readout timings: petosemtamab's frontline head and neck study will report in Q4 2026, while the second-line/third-line study will read in Q1 2027. Rina-S's two platinum-resistant ovarian cancer datasets (Phase II and Phase III) are both expected in Q4, and EPKINLY's EPCORE DLBCL-2 interim analysis will also read out in Q4.
Petosemtamab's Next Act
The expansion into colorectal cancer represents a significant upgrade in the asset's peak potential. As Ahmadi noted, "The totality of our data... underscores our conviction that Peto is the best-in-class second generation EGFR bispecific." This conviction is reinforced by cross-study comparisons against amivantamab, where peto consistently shows higher response rates and a differentiated safety profile. The company is initiating two Phase III trials—one frontline and one second-line—in RAS/RAF wild-type patients, leveraging the success of its earlier phase II data.
This move is particularly noteworthy as the competitive landscape in EGFR-directed therapies tightens, with J&J pursuing accelerated approval for amivantamab in head and neck. Amivantamab remains a key benchmark, but Genmab continues to differentiate through a comprehensive development plan.The data will be shared at ESMO in October, and these trials will position peto as a multi-indication asset.
A Dense Catalyst Calendar
The remainder of 2026 is packed with high-stakes readouts. For Rina S, the company anticipates both Phase II and Phase III data in platinum-resistant ovarian cancer by Q4. This is the first pivotal dataset for Rina-S, and management remains confident in its potential to be first-to-market and best-in-class. Similarly, EPKINLY's first-line DLBCL interim analysis is expected in Q4, a potential game-changer for the franchise. “We are well on track to deliver sustainable growth well into the next decade.” — Jan van de Winkel, Chief Executive Officer · 2026-08-06 The previous quarter, management had been more guarded about timing, with Tahamtan Ahmadi stating, "one or both of these studies will read out this year"—now we have precision, and the market will be watching closely.
The company's financial discipline is evident in the guidance, but the narrative is shifting from cost control to strategic investment. The two new Phase III trials in CRC will increase R&D spend, yet management only raised OpEx guidance by 2%. This operational leverage is a key point of differentiation. As Anthony Pagano put it: “The strength of our business also provides the financial flexibility to continue investing behind our highest value growth opportunities.” — Anthony Pagano, Chief Financial Officer · 2026-08-06
Competitive Stewardship
Genmab is also managing a complex competitive landscape. The company's response to the emerging topo-I resistance narrative is measured, with Tahi noting that this is "more a post-Rina problem," given the anticipated first-mover advantage. Meanwhile, the EPKINLY franchise continues to expand its community presence, with Brad Bailey highlighting that "the majority of new sites activated coming from community practices." This is a direct result of the dual-indication label and subcutaneous administration—features that resonate with dual indication in B-cell malignancies. The franchise's momentum supports management's confidence in the upcoming DLBCL readout, and the data could elevate EPKINLY into a standard-of-care backbone across multiple lines.
With three Phase III readouts due in the second half, Genmab is at an inflection point. The company's ability to execute across clinical, regulatory, and commercial fronts will determine whether it emerges as a leader in hematology and solid tumors alike. The current report suggests the foundation is solid, but the stakes are higher than ever.