Innovative Therapeutics in Oncology and Neuroscience slide image

Innovative Therapeutics in Oncology and Neuroscience

TIVDAK Strong Clinical Data Leading to Accelerated Approval in 2L+ Cervical Cancer with Clinical Development Ongoing in Other Indications Clinically Meaningful and Durable Responses, Combined with a Tolerable Safety Profile¹ Strong Mono Efficacy Data ■ A statistically significant and clinically meaningful improvement in OS - The hazard ratio for OS was 0.70, demonstrating a 30% reduction in the risk of death ■ Consistent benefit in PFS and confirmed ORR were supportive of the observed OS benefit with TIVDAK ◉ Most TRAEs were grade 1/2 Approved (U.S.) Broad TIVDAK Development Program in Front Line Cervical Cancer and Other Solid Tumor Trial innovaTV-204 2L+R/M, mono III Detail Phase Approved² Cervical innova TV-3013 2L+ global R/M, mono Cancer innova TV-205 1L R/M, combo with carboplatin and KEYTRUDA +/- bevacizumab I/II Other Tumors innova TV-207 1L+ locally advanced or metastatic disease in solid tumors4; mono and combo with KEYTRUDA and either carboplatin or cisplatin || Tolerable Safety Profile ☐ Most peripheral neuropathy events (known MMAE-related toxicity) were grade 1 and manageable ■ Ocular AEs were mostly mild to moderate, manageable with eye care plan . Zai Development Plan 1L CC and HNSCC: to consider joining global pivotal studies after global development plan confirmed • 2L+ CC: Joined the global Ph3 confirmatory study in 1Q 2023 31 Abbreviations: second line (2L), cervical cancer (CC), recurrent or metastatic (R/M), treatment-related adverse events (TRAE), adverse events (AE), Medically Attended Adverse Events (MMAE), Head and Neck Squamous Cell Carcinoma (HNSCC). Notes: (1) TIVDAK innovaTV-301 ESMO 2023 presentation; (2) FDA accelerated approval; continued approval may be contingent on verification and confirmation of clinical benefit in confirmatory trials; (3) Results from innovaTV 301 intended to serve as pivotal confirmatory trial for U.S. accelerated approval and to support global regulatory applications; (4) Includes colorectal cancer, pancreatic cancer, non-small cell lung cancer, and head and neck cancer. Clinical Data - Oncology
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