The Targeted Pulse: FDA Approvals in Ovarian Cancer, Lung Cancer, and More
The FDA has approved new agents in ovarian cancer and non–small cell lung cancer and paved the way for novel antibody-drug conjugate developments.
Avutometinib Plus Defactinib Gains FDA Approval in KRAS+ Ovarian Cancer
The FDA granted accelerated approval to the combination of avutometinib (VS-6766) plus defactinib (VS-6063; Avmapki Fakzynja co-pack) for adults with recurrent low-grade serous ovarian cancer harboring a KRAS mutation after at least 1 prior systemic therapy. This decision is supported by data from the phase 2 RAMP 201 (NCT04625270) and phase 1 FRAME (NCT03875820) trials.
RAMP 201 showed a 44% overall response rate (ORR) and a median duration of response (DOR) of 31.1 months in patients with KRAS-mutated tumors treated with the combination. The regimen was generally well tolerated, with the most common adverse events (AEs) being nausea, diarrhea, and increased blood creatine phosphokinase levels.
Read more about the approval here.
Quality-of-Life Improvement Is Highly Valued in Polycythemia Vera
Douglas Tremblay, MD, emphasizes the significance of quality-of-life data for patients with polycythemia vera (PV), who often live with the disease for many years. He highlights findings from the PROUD-PV (NCT01949805) and CONTINUATION-PV (NCT02218047) trials, which demonstrated that ropeginterferon alfa-2b-njft (Besremi) led to reduced symptom burden and less need for phlebotomy.
Tremblay, an assistant professor of medicine at the Icahn School of Medicine at Mount Sinai in New York, New York, notes that more symptomatic patients with PV may experience greater benefits. He stresses the importance of monitoring patient-reported symptoms using validated scores and considering potential treatment toxicities to assess the overall impact on quality of life. Open communication about expected benefits and potential AEs is crucial for patient care.
Watch the interview with Tremblay here.
FDA Fast-Tracks Novel ADC in Cervical Cancer
The FDA granted fast track designation to ADRX-0706, a Nectin-4-targeted antibody-drug conjugate (ADC), for the treatment of advanced cervical cancer. This designation aims to expedite the development and review of therapies for serious conditions with unmet medical needs.
ADRX-0706 is currently being evaluated in a phase 1a/b clinical trial for advanced solid tumors, including cervical cancer, in patients who have received prior systemic therapy. Early clinical signals for ADRX-0706 have been observed, and interim phase 1a data will be presented at the upcoming American Society of Clinical Oncology (ASCO) 2025 meeting.
Read the full story here.
FDA Clears IND for Novel DLL3-Targeted ADC in Solid Tumors
The FDA has cleared the IND application for IDE849 (SHR-4849), a novel delta-like ligand 3 (DLL3) topoisomerase-I ADC, allowing a phase 1 study in solid tumors to proceed. DLL3 is often upregulated in cancers like small cell lung cancer and neuroendocrine tumors.
Early phase 1 data shows IDE849 has reached therapeutic doses with reported partial responses and mostly low-grade AEs. Further dose escalation is ongoing, and IDEAYA Biosciences plans to explore IDE849 in combination with their PARG inhibitor, IDE161, based on preclinical synergy.
Learn more here.
FDA Grants Telisotuzumab Vedotin Accelerated Approval in c-MET+ NSCLC
The FDA granted accelerated approval to telisotuzumab vedotin-tllv (Teliso-V; Emrelis) for previously treated, locally advanced or metastatic nonsquamous non–small cell lung cancer with high c-MET protein overexpression, as identified by the VENTANA MET (SP44) RxDx Assay. This marks the first approved therapy for this specific patient group.
The approval is based on the phase 2 LUMINOSITY trial (NCT03539536), which demonstrated a 35% ORR and a median DOR of 7.2 months in patients with high c-MET expression. Common AEs included peripheral neuropathy and fatigue, while patient-reported quality of life was generally maintained. A confirmatory phase 3 trial is ongoing.
Check out the full story here.
