Taiho Oncology Inc., Taiho Pharmaceutical Co. Ltd., and Cullinan Therapeutics Inc. (NASDAQ:CGEM) on Thursday shared data from their global REZILIENT3 Phase 3 trial of zipalertinib in certain lung cancer patients.
The study met its primary endpoint of progression-free survival during a planned interim analysis.
“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,” said Jeffrey Jones, Chief Medical Officer, Cullinan Therapeutics.
In April, the U.S. Food and Drug Administration accepted a New Drug Application for zipalertinib for locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 20 insertion (ex20ins) mutations whose disease has progressed on or after platinum-based chemotherapy, with or without amivantamab.
The Prescription Drug User Fee Act target action date is February 27, 2027.
Evaluating Zipalertinib Efficacy
The REZILIENT3 trial was designed to compare the efficacy of the zipalertinib plus chemotherapy arm versus the chemotherapy arm.
The study enrolled 285 adults with previously untreated, locally advanced or metastatic non-squamous NSCLC with EGFR exon 20 insertion mutations.
The investigative regimen containing zipalertinib demonstrated a clinically meaningful and statistically significant enhancement in progression-free survival compared to the chemotherapy-alone group.
Manageable Safety and Regulatory Next Steps
In the analysis, the study demonstrated a statistically significant and clinically meaningful improvement in PFS in the zipalertinib-containing arm. Observed safety for the zipalertinib-containing arm was manageable.
Based on these data, the Independent Data Monitoring Committee recommended unblinding the study. The trial will continue to monitor efficacy and safety.
Earlier in August, the company reported cash, cash equivalents, short- and long-term investments, and interest receivable of $356 million as of June 30.
Cullinan expects its cash resources to provide runway into 2029.
Data from the Phase 2b part of the REZILIENT1 clinical trial of zipalertinib monotherapy supported the FDA application acceptance.
The confirmed objective response rate (ORR) was 35%. Median duration of response was 8.8 months.
In patients treated after prior platinum-based chemotherapy only (n=125), ORR was 40% with a mDOR of 8.8 months.
Analyst Weighs Zipalertinib Against Competing Treatments
William Blair on Thursday wrote, “Zipa’s strong efficacy and tolerability could prove beneficial in the first-line setting, where Johnson & Johnson’s (NYSE:JNJ) Rybrevant (amivantamab) plus chemotherapy is approved but has tolerability issues.”
AstraZeneca plc (NYSE:AZN) recently acquired Zegfrovy commercialization rights from Dizal Pharmaceutical. Hence, analyst Matt Phipps assumes Zegfrovy will soon be commercialized in the U.S.
CGEM Price Action: Cullinan Therapeutics shares were up 1.79% at $19.95 at the time of publication on Thursday. The stock is trading at a new 52-week high, according to Benzinga Pro data.
Lung Cancer-Photo by Komsan Loonprom via Shutterstock
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