Cullinan Oncology Inc. and Taiho Pharmaceutical Co., Ltd. announced an agreement through which Taiho will acquire Cullinan Pearl Corp. and co-develop and co-commercialize Cullinan Oncology’s lead program, CLN-081/TAS6417, an orally available, differentiated, irreversible EGFR inhibitor that selectively targets cells expressing EGFR exon 20 insertion mutations, while sparing cells expressing wild-type EGFR in non-small cell lung cancer.
The phase II COAST clinical trial demonstrated improved outcomes using immunotherapy combinations for patients with unresectable stage III non-small cell lung cancer, according to researchers at Yale Cancer Center, Cancer Center of Kansas, University of Colorado, Abramson Cancer Center, Astrazenaca, and collaborating international organizations.
The Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion and recommended granting marketing authorization for Tabrecta (capmatinib) as a monotherapy for the treatment of adults with advanced non-small cell lung cancer harboring alterations leading to mesenchymal-epithelial-transition factor gene exon 14 (METex14) skipping who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.
FDA accepted the supplemental Biologics License Application of Enhertu (fam-trastuzumab deruxtecan-nxki), a HER2-directed antibody drug conjugate, for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer whose tumors have a HER2 (ERBB2) mutation and who have received a prior systemic therapy. The application has also been granted Priority Review.
FDA has approved for FoundationOne CDx to be used as a companion diagnostic to identify patients with non-small cell lung cancer whose tumors have epidermal growth factor receptor exon 19 deletions or exon 21 (L858R) alterations and are appropriate for treatment with EGFR tyrosine kinase inhibitors approved by FDA for this indication.
FDA approved Opdivo (nivolumab) with platinum-doublet chemotherapy for adult patients with resectable non-small cell lung cancer in the neoadjuvant setting.
FDA has granted Breakthrough Therapy designation for CLN-081 for the treatment of patients with locally advanced or metastatic non-small cell lung cancer harboring epidermal growth factor exon 20 insertion mutations who have previously received platinum-based systemic chemotherapy.
FDA has granted Fast Track designation to Reqorsa (quaratusugene ozeplasmid), a pan-kinase inhibitor, plus Keytruda (pembrolizumab) in patients with histologically-confirmed unresectable stage III or IV non-small cell lung cancer whose disease progressed after treatment with Keytruda.
A phase II trial investigating the anti-TIGIT cancer immunotherapy tiragolumab plus Tecentriq (atezolizumab) compared with Tecentriq alone as a first-line treatment for people with PD-L1-positive metastatic non-small cell lung cancer showed that the combination improved progression-free survival.
FDA has granted premarket approval to Thermo Fisher Scientific’s Oncomine Dx Target Test as a companion diagnostic to help identify non-small cell lung cancer patients whose tumors carry epidermal growth factor receptor Exon20-insertion mutations for potential treatment with Rybrevant (amivantamab-vmjw), Janssen Biotech Inc.’s targeted therapy.
