Zipalertinib
Sylvester Comprehensive Cancer Center to Present Groundbreaking Research at ASCO 2025 Annual Meeting
• Researchers from Sylvester Comprehensive Cancer Center will deliver 9 oral presentations, 4 rapid oral presentations, and 51 poster presentations at the upcoming ASCO 2025 Annual Meeting, showcasing significant advances across multiple cancer types.
• Highlighted studies include the ADVANCE clinical trial examining novel multiple myeloma treatments, innovative virtual reality interventions for stem cell transplant patients, and groundbreaking research on alcohol-related cancer mortality in the US.
• The extensive research portfolio demonstrates Sylvester's leadership in developing cutting-edge cancer therapies, addressing health disparities, and improving supportive care for diverse patient populations.
Cullinan Therapeutics Advances Novel CD19 T Cell Engager to Phase 1 Trial for Rheumatoid Arthritis in Europe
• The European Medicines Agency has approved Cullinan Therapeutics' Clinical Trial Application for CLN-978, a CD19xCD3 bispecific T cell engager, to begin Phase 1 trials in rheumatoid arthritis patients.
• CLN-978 offers potential advantages over existing therapies, including deeper B cell depletion, convenient subcutaneous administration, and off-the-shelf accessibility for patients with difficult-to-treat rheumatoid arthritis.
• The company-sponsored trial will commence in Q2 2025 at leading European research institutions, while Cullinan simultaneously advances CLN-978 studies for systemic lupus erythematosus across global sites.
Cullinan Management's Zipalertinib Shows Promise in NSCLC, Bolstering Stock Rating
• Cullinan Management's zipalertinib met its primary endpoint in a Phase 2b trial for non-small cell lung cancer (NSCLC), demonstrating a promising overall response rate.
• The success of the REZILIENT1 study and a strategic partnership with Taiho Pharmaceutical have led to an increased 'Buy' rating from analysts.
• Zipalertinib's potential launch in the U.S. market is projected to generate significant sales, with estimates reaching $397 million by 2031.
• Positive trial outcomes and ongoing studies of other pipeline candidates like CLN-978 and CLN-619 further support Cullinan's growth prospects.
Zipalertinib Shows Promise in NSCLC with EGFR Exon 20 Insertion Mutations
• Zipalertinib achieved the primary endpoint of overall response rate (ORR) in the REZILIENT1 trial for NSCLC patients with EGFR exon 20 insertion mutations.
• Patients pretreated with amivantamab only showed a 50% ORR, while those with prior amivantamab and other exon 20-directed agents had a 25% ORR.
• The safety profile of zipalertinib was consistent with prior findings, with manageable treatment-related adverse events.
• Regulatory submission for zipalertinib in the U.S. is planned for the second half of 2025, pending FDA discussions.
Arvinas Advances Vepdegestrant into Phase 3 Trials for Breast Cancer and Updates Pipeline Milestones
• Arvinas plans to initiate two Phase 3 trials in 2025 for vepdegestrant in ER+/HER2- metastatic breast cancer, one in the first-line setting with atirmociclib and another in the second-line setting with a CDK4/6 inhibitor.
• Topline data from the Phase 3 VERITAC-2 monotherapy trial of vepdegestrant in second-line-plus ER+/HER2- metastatic breast cancer is anticipated in the first quarter of 2025.
• Arvinas is set to present initial data from the Phase 1 trial of ARV-393 in B-cell lymphomas and file an IND application for a novel PROTAC KRAS G12D degrader in 2025.
• Phase 1 trial with PROTAC LRRK2 degrader ARV-102 in patients with Parkinson’s disease has been initiated, with data expected to be presented in the first half of 2025.
China Approves Zorifer for NSCLC with Brain Metastases, Addressing Critical Treatment Gap
China's NMPA has approved Zorifer (zorifertinib), a novel EGFR-TKI developed by Alpha Biopharma and AstraZeneca, for treating non-small cell lung cancer (NSCLC) with CNS metastases. The drug demonstrated significant efficacy in the EVEREST trial, showing a 37% reduction in intracranial progression risk and 17.9-month progression-free survival compared to first-generation EGFR-TKIs.
Zipalertinib Shows Promise in EGFR Exon 20-Mutated NSCLC After Amivantamab Failure
• Zipalertinib demonstrates promising efficacy in heavily pretreated NSCLC patients with EGFR exon 20 insertion mutations who progressed after amivantamab treatment.
• In patients previously treated with amivantamab alone, zipalertinib achieved an objective response rate of 50%, including one complete response.
• The disease control rate with zipalertinib was high across all subgroups, reaching 90% in the overall population and 88.9% in the amivantamab-only group.
• Common treatment-related adverse events included rash (38%) and paronychia (36%), with manageable grade 3 or higher events like anemia (9%).
Novel Strategies Emerge to Optimize Treatment in EGFR-Mutant NSCLC
• Research at ESMO Congress 2024 highlights the importance of understanding resistance mechanisms in EGFR-mutant NSCLC to improve treatment outcomes.
• Amivantamab plus chemotherapy demonstrates a deepening survival benefit post-osimertinib progression, marking it as a potentially effective second-line regimen.
• Zipalertinib shows promising anti-tumor activity in EGFR exon 20 insertion-mutated NSCLC patients who progressed on amivantamab, with manageable toxicity.
• Molecular resistance testing at disease progression is crucial for personalized treatment choices, including chemotherapy, antibody-drug conjugates, and other combinations.
Cullinan Oncology and Taiho Pharmaceutical Forge $275M Strategic Collaboration for EGFR Inhibitor CLN-081/TAS6417
• Taiho Pharmaceutical will acquire Cullinan Pearl for $275 million upfront plus up to $130 million in regulatory milestones, gaining exclusive global rights to CLN-081/TAS6417 outside the U.S.
• CLN-081/TAS6417 is an oral, irreversible EGFR inhibitor targeting exon 20 insertion mutations in non-small cell lung cancer, which affect approximately 2-3% of NSCLC patients globally.
• The companies will jointly develop and co-commercialize the drug in the U.S. with equal profit sharing, while Taiho will commercialize in territories outside the U.S. and China.
Drug Development Updates
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