On November 12, 2021 Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") reported the peer-reviewed publication of significant results from a pivotal study of abivertinib on 227 heavily pretreated NSCLC patients in the journal Clinical Cancer Research, authored by Dr. Yi-Long Wu, distinguished professor of Guangdong Lung Cancer Institute, awardee of the prestigious "International Association for the Study of Lung Cancer (IASLC) Scientific Award" in 2017, and the principal investigator of the study (Press release, Sorrento Therapeutics, NOV 12, 2021, View Source [SID1234595509]).

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The full manuscript is available at: View Source

Abivertinib is a pyrrolopyrimidine-based, third-generation EGFR/BTK inhibitor, which is structurally distinct from osimertinib. Abivertinib selectively inhibits EGFR-activating and resistant mutation with nearly 300-fold potency as compared with wild-type EGFR. The 300 mg BID abivertinib dose was based upon the pharmacokinetics, efficacy and safety profiles characterized in prior studies. In the pivotal study, 227 patients received this dose for a median treatment duration of 24.6 weeks (0.43-129). Among 209 response evaluable patients, confirmed ORR was 52.2% (109/209; 95% CI: 45.2%, 59.1%) and the DCR was 88.0% (184/209, 95% CI: 82.9%, 92.1%). The median DoR and PFS were 8.5 months (95% CI: 6.1, 9.2) and 7.5 months (95% CI: 6.0, 8.8), respectively. The median OS was 24.9 months (95% CI: 22.4, NR). All patients (N=227) reported at least 1 AE, with 96.9% (220/227) reporting treatment-related AEs. Treatment-related serious AEs were reported in 13.7% (31/227) of patients. Death was reported in 4.4% (10/227) of patients, and none was deemed related to abivertinib.

With the ORR of 52.2%, and OS of 24.9 months, comparable to approved 3rd generation EGFR inhibitors, abivertinib demonstrated significantly efficacious effects in overcoming resistant mutation in NSCLC. Based on these results, Sorrento is conducting an independent review process with long-term follow up data and intends to request a pre-NDA meeting with FDA. "We are very encouraged by the publication of these significant positive results of abivertinib on the treatment of advanced and heavily pretreated NSCLC lung cancer in Clinical Cancer Research and look forward to bringing abivertinib into the armamentarium of this multi-billion dollar indication," said Dr. Henry Ji, Chairman and CEO of Sorrento.