IMPACT Therapeutics’ IMP4297 and Temozolomide Receives the US FDA’s Orphan Drug Designation for Small Cell Lung Cancer
- The US FDA has granted ODD to a fixed-dose combination capsule of senaparib (PARP inhibitor) and temozolomide (TMZ) to treat SCLC
- The company is currently conducting the P-Ib/II dose escalation & expansion study to evaluate the safety, tolerability, PK, and anti-tumor efficiency of senaparib + temozolomide in 113 patients with advanced solid tumors and small cell lung cancer across the US, Australia, South Korea, and other countries and regions
- In the preliminary results, senaparib + temozolomide showed ORR (33.3%) incl. 3 confirmed PR, DCR (83.3%), m-DoR (3.6mos.) while the 2 patients were still on treatment @ ≥1yr. for advanced solid tumor. Additionally, ORR (42.9%) incl. 2 confirmed PR
Ref: Globe Newswire | Image: Impact
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