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Significant Positive Pivotal Trial Results as Assessed by an Independent Review Committee (IRC) With Matured Long-Term (Over Three Years) Follow-Up Data of Abivertinib for the Treatment of Advanced Non-Small Cell Lung Cancer

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Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) today announced positive results from a pivotal study of Abivertinib on 209 response evaluable, heavily pretreated NSCLC patients by an IRC assessment with matured long-term follow up data.

Abivertinib is a pyrrolopyrimidine-based, third-generation EGFR inhibitor, which is structurally distinct from osimertinib. Abivertinib selectively inhibits EGFR-activating and resistant mutation with nearly 300-fold greater potency as compared with wild-type EGFR. Previously, a positive interim result assessed by investigators was published in the peer-reviewed Clinical Cancer Research journal with interim data (https://clincancerres.aacrjournals.org/content/early/2021/11/04/1078-0432.CCR-21-2595).

In these IRC-assessed preliminary topline results with more matured long-term follow up data (previously 16.8 months, now 38.8 months), Abivertinib showed significant treatment benefits in 209 response evaluable, heavily treated NSCLC patients with ORR of 56.5%, and notably a significant CR rate was seen with Abivertinib (5.3%) in comparison with that of osimertinib (Tagrisso) (0.5%)*, while the ORR rate is comparable between the two drugs. This combined data, the ORR of 56.5%, the CR rate of 5.3%, and median OS of 28.2 months (versus Tagrisso’s median OS of 26.8 months)**, is potentially superior to that of the approved third generation EGFR inhibitor (osimertinib). Abivertinib demonstrated significantly efficacious effects in overcoming the resistant mutation in NSCLC. Based on these results, Sorrento is closing the study and preparing the pre-NDA materials and NDA package. Sorrento will request a pre-NDA meeting with the FDA and other regulatory agencies around the world with potential NDA filings pending agreements with the regulatory agencies in different countries.

“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,” said Dr. Henry Ji, Chairman and CEO of Sorrento. Abivertinib is one of the multiple clinical and pre-clinical stage assets obtained by Sorrento in the previously completed acquisition of ACEA Therapeutics, Inc. in June of 2021.

*https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/208065Orig1s000MedR.pdf

** https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208065s025lbl.pdf

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