Nektar Therapeutics (Nasdaq: NKTR) today announced preliminary progression-free survival data from the first stage of a two-stage Phase 2 clinical study evaluating single-agent treatment with NKTR-102 in women with platinum-resistant ovarian cancer. In the first stage of the study, 39 patients were enrolled with platinum-resistant disease and were evaluable for the secondary endpoint of progression-free survival (PFS).
The study showed that women who received NKTR-102 once every 21 days (q21 day) had a median PFS of 21.0 weeks. In the second arm of the study, women who received NKTR-102 once every 14 days (q14 day) had a median PFS of 12.2 weeks. Progression-free survival is a measure of how long patients live without their disease advancing. Current agents approved by the U.S. Food & Drug Administration to treat women with platinum-resistant ovarian cancer have median PFS of between 9.1 and 13.6 weeks.
"NKTR-102 has demonstrated a progression-free survival time of nearly five months, which is remarkable for a largely refractory population that is expected to have a PFS of less than three months," said Lorianne Masuoka, M.D., Senior Vice President and Chief Medical Officer. "With a confirmed objective GCIG response rate of 35 percent also in the every three week dose schedule and a favorable toxicity profile, NKTR-102 appears to offer great promise to women with chemo-resistant ovarian cancer. We look forward to sharing additional data when all patients have concluded both stages of the study."