Genmab A/S（GMAB）資訊與事件GMABGenmab A/S

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.

Genmab Phase 3 Ovarian Cancer Trial Meets Primary Endpoint

Genmab says Phase 3 ovarian cancer trial met primary endpoint

Genmab Q3 Darzalex Sales Reach $4.239M

Genmab announced that worldwide net trade sales of Darzalex - daratumumab -, including sales of the subcutaneous product sold under the tradename Darzalex Faspro in the U.S., as reported by Johnson & Johnson (JNJ), were $4.239M in Q3. Net trade sales were $2.528M in the U.S. and $1.711M in the rest of the world. Genmab receives royalties on the worldwide net sales of Darzalex, both the intravenous and SC products, under the exclusive worldwide license to J&J to develop, manufacture and commercialize daratumumab.