REG-Genmab Announces Rinatabart Sesutecan (Rina-S®) Phase 2 RAINFOL™-01 Results Demonstrated Durable and Clinically Meaningful Responses in Patients with Platinum-Resistant Ovarian Cancer
Key Highlights
- ➤Rina-S achieved 45.9% confirmed objective response rate in 109 platinum-resistant ovarian cancer patients
- ➤Rina-S delivered 12.1-month median duration of response, with 51% responding at one year
- ➤Rina-S showed 9.5-month median progression-free survival in platinum-resistant ovarian cancer
- ➤Antitumor activity occurred across FRα expression levels and regardless of prior mirvetuximab treatment
- ➤Phase 3 Rina-S program advances across ovarian, endometrial, and other gynecologic cancers
Expert Statements
Elizabeth K. Lee, M.D., study investigator and medical oncologist, Dana-Farber Cancer Institute
“Platinum-resistant ovarian cancer is a difficult-to-treat disease. As patients relapse and progress through successive lines of therapy, achieving durable clinical benefit becomes increasingly challenging, yet remains critically important”
Elizabeth K. Lee, M.D., study investigator and medical oncologist, Dana-Farber Cancer Institute
“The antitumor activity and durability observed with Rina-S in this heavily pretreated population are encouraging and suggest the potential to meaningfully impact outcomes for patients facing a particularly challenging stage of disease”
Tahamtan Ahmadi, M.D., Ph.D., Executive Vice President and Chief Medical Officer, Head of Experimental Medicines, Genmab
“The late-breaking results presented today add an important layer of evidence to the growing clinical experience with Rina-S in patients with platinum-resistant ovarian cancer”
Tahamtan Ahmadi, M.D., Ph.D., Executive Vice President and Chief Medical Officer, Head of Experimental Medicines, Genmab
“These findings, including the observed antitumor activity, duration of response, and the first progression-free survival data reported for the program, as well as the manageable tolerability, reinforce the potential of Rina-S. As our Phase 3 program continues to advance, the results further inform our evaluation of Rina-S as a potential treatment option for patients with gynecologic cancers”
COPENHAGEN, Denmark; October 3, 2026 * Treatment with Rina-S(®) 120 mg/m² every three weeks demonstrated a clinically meaningful objective response rate (ORR) and durable median duration of response (mDOR) in patients with platinum-resistant ovarian cancer (PROC) * Antitumor activity was observed regardless of folate receptor alpha (FRα) expression levels, including low FRα expression and non-expressors Genmab A/S (Nasdaq: GMAB) today announced results from Part C of the Phase 1/2 RAINFOL™-01 trial evaluating rinatabart sesutecan (Rina-S), an investigational folate receptor alpha (FRα)-targeted, topoisomerase I (TOPO1)-inhibitor antibody-drug conjugate (ADC), demonstrated that among 109 treated patients with platinum-resistant ovarian cancer (PROC), Rina-S achieved a confirmed objective response rate (ORR) of 45.9% (95% CI: 36.3–55.7), including five complete responses (CRs) and a median duration of response (mDOR) of 12.1 months (95% CI: 6.5–15.4), with 51% of responders remaining in response at one year. The findings were presented today in a Late-Breaking Oral Session at the International Gynecologic Cancer Society (IGCS) Congress 2026, held in Montreal, Canada.
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