Dr Gonzalez-Martin on the Efficacy of TUB-040 in Ovarian Cancer

“In this heavily pretreated patient population, we observed an unconfirmed ORR of 59% and a confirmed ORR of 50%, including 1 complete response.”

Antonio Gonzalez-Martin, MD, the head of the Department of Medical Oncology at Clinica Universidad de Navarra, the director of the Cancer Center Clinica Universidad de Navarra, and an associate professor of medicine at Francis, discussed the key efficacy data from the phase 1/2a NAPISTAR1-01 trial (NCT06303505) of the novel antibody-drug conjugate TUB-040 in patients with platinum-resistant, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Findings from NAPISTAR1-01 presented during the 2025 ESMO Congress showed that patients who received TUB-040 at the 1.67 mg/kg to 3.3 mg/kg dose range (n = 46) achieved an overall response rate (ORR) of 59% and a confirmed ORR of 50%, including 1 patient with a complete response, Gonzalez-Martin. The disease control rate (DCR) and confirmed DCR were both 96%. He added that the population was heavily pretreated, with 83.6% of patients in the overall population (n = 67) having received prior bevacizumab (Avastin) and 76.1% of patients having received a prior PARP inhibitor.

Gonzalez-Martin noted that responses were observed even in patients who received TUB-040 at lower dose levels. Specifically, patients in the 1.67-mg/kg cohort (n = 10) experienced an ORR of 60%, a confirmed ORR of 40%, and a DCR and confirmed DCR of 90%.

Additional findings presented during the meeting showed that the CA125 response rate across the 1.67-mg/kg to 3.3-mg/kg doses was 81%. Ninety-three percent (n = 25/27) of patients who responded were in an ongoing response at the data cutoff, and 80% (n = 37/46) of patients were remaining on treatment, indicating a durable benefit according to the study authors.

Disclosures: Gonzalez-Martin reported receiving research grants from GSK, Roche, ISCiii, and AECC; having advisor roles with Alkermes, Amgen, AstraZeneca, Clovis, Genmab, GSK, HederaDx, AbbVie/Immunogen, Incyte, Illumina, Mersana, MSD, Novartis, Novocure, Oncoinvent, PharmaMar, Regeneron, Roche, SOTIO, SUTRO, Seagen, Takeda, Tubulis, and Zalia; providing expert testimony for AstraZeneca, Clovis, GSK, Immunogen, Mersana, MSD, Novocure, PharmaMar, Roche, Takeda, Seagen, and ZaiLab; being the chairman of GEICO; and receiving travel support from AstraZeneca/MSD and GSK.