Sorrento Therapeutics Inc (NASDAQ: SRNE) has announced positive findings from its pivotal Abivertinib study in 209 response-valued, highly pretreated patients with NSCLC through an IRC evaluation with extended follow-up data.
EGFR blocker abivertinib differs structurally from osimertinib
The 3rd generation EGFR blocker abivertinib is based on pyrrolopyrimidines and differs fundamentally from osimertinib. Compared to EGFR, which is wild-type, abivertinib specifically suppresses EGFR-expressing and resistant mutations with almost 300-fold more potency. In addition, the company announced the publication of investigator-assessed encouraging preliminary results in the peer-reviewed journal of Clinical Cancer Research.
Abivertinib demonstrated substantial therapeutic benefit in 209 response valid and reliable, largely medicated NSCLC individuals with an ORR of 56.5% in such IRC-assessed initial topline findings with more developed extended follow-up information (initially 16.8 months, presently 38.8 months). Of note, a substantial CR percentage was observed with Abivertinib (5.3%) in contrast to osimertinib (Tagrisso) (0.5%). The average OS of 28.2 months, ORR of 56.5%, and CR incidence of 5.3% provide combined results that may be better than those of the 3rd generation EGFR inhibitors that have been cleared.
Abivertinib shows effective results in treating NSCLC patients
When used to treat NSCLC, abivertinib showed markedly effective results against the refractory mutation. Sorrento is wrapping up the trial and getting ready to submit the pre-NDA and NDA files in light of these findings. With possible NDA files pending arrangements with the government regulators in various countries, Sorrento will ask for a pre-NDA briefing with the US FDA and other government regulators worldwide.
CEO and Chairman of Sorrento Dr. Henry Ji said, “We are very encouraged by the significant positive results of Abivertinib assessed by the IRC with long-term follow-up data and look forward to meeting with the FDA and other regulatory authorities for the possibility of bringing Abivertinib to the U.S. and global markets.”
Among the numerous assets in the pre-clinical and clinical stages acquired by Sorrento in the recently finished purchase of ACEA Therapeutics in June 2021 is abivertinib.