PRINCETON, N.J. — Taiho Oncology, Inc., Taiho Pharmaceutical Co., Ltd., and Cullinan Therapeutics, Inc. said the Phase 3 REZILIENT3 trial of zipalertinib in combination with platinum-based chemotherapy met its primary endpoint of progression-free survival in patients with previously untreated EGFR exon 20 insertion-mutated non-small cell lung cancer.
The global study compared zipalertinib plus platinum-based chemotherapy with chemotherapy alone as a first-line treatment for adults with locally advanced or metastatic non-small cell lung cancer, or NSCLC, harboring EGFR exon 20 insertion mutations.
At a planned interim analysis, the zipalertinib combination demonstrated a statistically significant and clinically meaningful improvement in progression-free survival, the companies said. The treatment arm also showed a manageable safety profile.
Based on the results, the study’s Independent Data Monitoring Committee recommended that the trial be unblinded. The study will continue to monitor efficacy and safety.
The companies said full results from REZILIENT3 will be submitted for presentation at an upcoming international medical conference.
Taiho Oncology, Taiho Pharmaceutical and Cullinan Therapeutics also plan to discuss the findings with the U.S. Food and Drug Administration and pursue U.S. regulatory approval for the combination as a first-line treatment.
“The positive topline results from the planned interim analysis of REZILIENT3 further support the potential of zipalertinib to meet the high unmet medical need in patients with NSCLC harboring EGFR exon 20 insertion mutations,” said Harold Keer, M.D., Ph.D., Chief Medical Officer of Taiho Oncology. “We look forward to pursuing regulatory approval of zipalertinib in combination with chemotherapy in the first-line treatment setting with the goal of providing a new treatment option for this group of patients.”
Fabio Benedetti, M.D., Global Chief Medical Officer of Taiho Pharmaceutical, said the Phase 3 results represent an important milestone for the program.
“Zipalertinib is a compound created through Taiho Pharmaceutical’s proprietary drug discovery technology,” Benedetti said. “Achieving positive results in this Phase 3 trial in the first-line setting represents an important milestone for this program. We will continue to work closely with Taiho Oncology and Cullinan Therapeutics to bring zipalertinib in combination with chemotherapy to patients as soon as possible.”
Jeffrey Jones, M.D., MBA, Chief Medical Officer of Cullinan Therapeutics, said meeting the primary endpoint at the interim analysis supports zipalertinib’s potential role in first-line treatment.
“These topline results give us confidence in the potential for zipalertinib to offer a first-line treatment option for patients with NSCLC with EGFR exon 20 insertion mutations,” Jones said.
