Sorrento Announces Publication of Significant Positive Pivotal Trial Results of Abivertinib for the Treatment of Non-Small Cell Lung Cancer (NSCLC) in the Peer-Reviewed Journal Clinical Cancer Research

• Abivertinib is a novel third-generation epidermal growth factor receptor (EGFR) inhibitor that irreversibly targets mutant forms of EGFR and Bruton’s tyrosine kinase (BTK) in advanced NSCLC patients resistant to first-line EGFR kinase inhibitor therapies.
  
• In this pivotal study conducted in China, 227 heavily pretreated NSCLC patients were enrolled and among 209 response evaluable patients, confirmed overall response rate (ORR) was 52.2%. Disease control rate (DCR) was 88.0%. The median duration of response (DoR) and progression-free survival (PFS) was 8.5 months and 7.5 months, respectively. The median overall survival (OS) was 24.9 months.
• Based on these significant treatment benefits that Abivertinib achieved in a heavily pretreated population, Sorrento is conducting an independent review process with more mature long-term data and will request a pre-NDA meeting with the FDA upon completion.

Excerpt from the Press Release:

SAN DIEGO, Nov. 12, 2021 (GLOBE NEWSWIRE) — Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) today announced 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.

The full manuscript is available at: https://clincancerres.aacrjournals.org/content/early/2021/11/04/1078-0432.CCR-21-2595

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.

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