Sorrento Therapeutics Inc. (OTCMKTS: SRNE) announced positive long-term results for its third-generation EGFR inhibitor abivertinib in a pivotal trial for advanced non-small cell lung cancer (NSCLC). The study, conducted exclusively in China, enrolled 209 patients with EGFR-mutated lung cancer previously treated with first-generation EGFR inhibitors.
Trial Results
- Overall Response Rate (ORR): 56.5% as assessed by the Independent Review Committee (IRC).
- Complete Responses (CR): 11 patients (5.3%) achieved CR.
- Median Overall Survival (OS): 28.2 months.
The data is being prepared for a pre-New Drug Application (NDA) meeting with the US FDA, with potential regulatory filings in other markets.
Drug Profile
Abivertinib, acquired by Sorrento through the USD 488 million purchase of ACEA Therapeutics in June 2021, is structurally distinct from AstraZeneca’s Tagrisso (osimertinib). While ORR data is comparable, abivertinib demonstrated a 5.3% CR rate and 28.2-month OS, potentially superior to Tagrisso’s 0.5% CR and 26.8-month OS.
Strategic Outlook
Sorrento’s CEO Henry Ji expressed optimism about the results and plans to engage with the FDA and other regulators. However, the company currently relies solely on China-based data, as the US FDA has recently rejected oncology NDAs from HutchMed, Innovent, and Junshi Bio, citing the need for multi-regional trials including US patients. Sorrento has no ongoing US trials for abivertinib in NSCLC, according to ClinicalTrials.gov.-Fineline Info & Tech
