India, Nov. 15 -- Summit Therapeutics Inc. (SMMT) announced that the FDA issued complete response letter (CRL) for its Biologics License Application for ivonescimab, a PD-1 x VEGF bispecific antibody, plus platinum-based chemotherapy for locally advanced or metastatic non-small cell lung cancer in patients who previously received an EGFR tyrosine kinase inhibitor.
The FDA said substantial evidence of effectiveness requires statistically significant overall survival improvement, and that progression-free survival benefit alone cannot support approval.
In the HARMONi Phase III trial, overall survival showed a positive trend but missed statistical significance. A post-hoc analysis of longer follow-up showed a hazard ratio of 0.76 across the ...