Onco-Summaries: Daily Oncology Updates at a Glance

26/08/2025

Genmab's Rina-S ADC received the Breakthrough Therapy Designation from the FDA for endometrial cancer (Ref)

The US FDA granted the Breakthrough Therapy Designation to Genmab's rinatabart sesutecan (FRα-directed, TOPO1-inhibitor ADC), for the treatment of adult patients with recurrent or progressive endometrial cancer who have disease progression on or following prior treatment with a platinum-containing regimen and a PD-(L)1 therapy.

• The designation was based on results from the endometrial cancer monotherapy dose expansion B2 cohort of the Phase 1/2 RAINFOL-01 trial (NCT05579366)

  
  

• Judith Klimovsky, Executive Vice President and Chief Development Officer, Genmab: “This Breakthrough Therapy Designation underscores the future potential of Rina-S as a treatment option for women diagnosed with advanced endometrial cancer, who face a poor prognosis after progressing on standard of care treatment. Rina-S reinforces Genmab’s determination to advance wholly owned antibody medicines in areas long overdue for innovation and our commitment to driving a strong clinical development program to help redefine what’s possible to treat gynecologic cancers.”

Allarity Therapeutics' stenoparib received the Fast Track Designation for ovarian cancer (Ref)

The US FDA granted the Fast Track Designation to Allarity Therapeutics' stenoparib (dual PARP and WNT pathway inhibitor) for patients with advanced ovarian cancer.

• Thomas Jensen, CEO, Allarity Therapeutics: “We are very pleased that the FDA has granted Fast Track designation to stenoparib. This recognition underscores the significant unmet need facing women with advanced ovarian cancer and reflects the potential of stenoparib to meaningfully improve treatment outcomes. We look forward to engaging closely with the FDA as we advance this program.”

Akeso & Summit's ivonescimab + chemo met the OS endpoint in the Phase 3 HARMONi-A trial (Ref)

Per final analysis of the Phase 3 HARMONi-A trial, a statistically significant and clinically meaningful OS benefit was observed with Akeso & Summit's ivonescimab (anti-PD-1/VEGF bispecific antibody) + chemotherapy in patients with EGFR-mutant non-squamous NSCLC who progressed on EGFR tyrosine-kinase inhibitor treatment.

• Akeso statement: "As the first phase 3 final analysis for ivonescimab, these results not only reinforce its breakthrough value in progression-free survival (PFS), but also highlight its ability to deliver significant OS improvement, a key endpoint in global oncology drug development"