abivertinib

An overall response rate of 56.5% was seen in a pivotal study of Sorrento Therapeutics’ (NASDAQ:SRNE) investigational drug abivertinib for non-small cell lung cancer.

Additionally, 11 patients achieved complete responses (“CR”), for a CR rate of 5.3% and a median overall survival of 28.2 months, according to the findings.

The trial participants received extensive pretreatment.

Third-generation EGFR inhibitor abivertinib is based on pyrrolopyrimidines and differs structurally from osimertinib. When compared to EGFR that is wild-type, abivertinib specifically suppresses EGFR-activating and resistant mutations with almost 300-fold more potency. A favorable interim outcome that has been evaluated by researchers was previously reported with interim data in the peer-reviewed journal Clinical Cancer Research.

Abivertinib demonstrated significant treatment benefits in 209 response evaluable, heavily treated NSCLC patients with an ORR of 56.5% in these IRC-assessed preliminary topline results with more matured long-term follow-up data (previously 16.8 months, now 38.8 months). In addition, a significant CR rate was observed with Abivertinib (5.3%) in comparison to that of osimertinib (Tagrisso) (0.5%).

This data, which includes an ORR of 56.5%, a CR rate of 5.3%, and a median OS of 28.2 months (compared to Tagrisso’s median OS of 26.8 months)**, suggests that it may be more effective than the third-generation EGFR inhibitor that has been given approval (osimertinib). When used to treat NSCLC, abivertinib showed markedly effective results against the resistant mutation. Sorrento is wrapping up the study and getting ready to submit the pre-NDA documents and NDA package in light of these findings. With possible NDA files pending agreements with the regulatory agencies in various countries, Sorrento will ask for a pre-NDA meeting with the FDA and other regulatory agencies across the world.

According to the findings, Sorrento (NASDAQ:SRNE) said that it is ending the trial and getting ready for a pre-New Drug Application meeting with the US FDA.

Sorrento is a biopharmaceutical business in the clinical and commercial stages that is working to create novel medicines for COVID-19, autoimmune diseases, cancer, and pain (using non-opioid painkillers).

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