ALPHAMAB-B(09966): Latest progress in Phase III clinical trial of KN046 for the treatment of advanced squamous NSCLC.

ALPHAMAB-B (09966) announced that the III phase clinical trial study code of KN046, ENREACH-LUNG-01 ("KN046-301"), was unable to successfully complete unblinding due to the lack of statistically significant difference in overall survival ("OS"). The Independent Data Monitoring Committee recommended to continue the study and further collect subsequent OS data until the final OS analysis in May 2023. KN046-301 is a multicenter, randomized, double-blind, placebo-controlled III phase clinical trial designed to evaluate the efficacy and safety of KN046 (a recombinant humanized bispecific antibody targeting programmed death ligand 1 ("PD-L1")/cytotoxic T-lymphocyte-associated protein 4 ("CTLA-4") invented and developed by the company) combined with platinum-based chemotherapy in patients with advanced unresectable or metastatic squamous non-small cell lung cancer ("sq NSCLC"). To maximize the benefit for the subjects, the study design allows patients in the chemotherapy group to receive cross treatment with KN046 monotherapy or other approved anti-PD-1/PD-L1 immune checkpoint inhibitors by the National Medical Products Administration ("NMPA") after disease progression. KN046-301 completed its first interim analysis in March 2022 and met the pre-specified progression-free survival ("PFS") endpoint. The interim analysis results showed that KN046 combined with platinum-based chemotherapy achieved a statistically significant and clinically meaningful improvement in PFS in sq NSCLC patients compared to chemotherapy alone, meeting the pre-defined efficacy criteria. The final OS analysis of KN046-301 showed a statistically significant OS benefit in sq NSCLC patients treated with KN046 combined with platinum-based chemotherapy compared to placebo combined with platinum-based chemotherapy after adjusting for the impact of cross immunotherapy. Furthermore, the final analysis of PFS showed a significant benefit in the KN046 combined with platinum-based chemotherapy group. The company will conduct a thorough analysis of the KN046-301 data, present it at industry conferences, and determine the next steps. Due to uncertainties in the review and approval process by the NMPA Center for Drug Evaluation, the company cannot guarantee acceptance and approval of the new drug application for KN046 in the treatment of sq NSCLC.