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 -
OncologyView entire presentation