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
About
Sorrento is a clinical and commercial stage biopharmaceutical company developing new therapies to treat cancer, pain (non-opioid treatments), autoimmune disease and COVID-19. Sorrento's multimodal, multipronged approach to fighting cancer is made possible by its extensive immuno-oncology platforms, including key assets such as fully human antibodies ('G-MAB library'), immuno-cellular therapies ('DAR-T'), antibody-drug conjugates ('ADCs'), and oncolytic virus ('Seprehvec'). Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including Abivertinib, COVIGUARD, COVI-AMG, COVISHIELD, COVI-MSC and COVIDROPS; and diagnostic test solutions, including COVITRACK, COVISTIX and COVITRACE.
Sorrento's commitment to life-enhancing therapies for patients is also demonstrated by our effort to advance a first-in-class (TRPV1 agonist) non-opioid pain management small molecule, resiniferatoxin ('RTX'), and SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (SEMDEXA), a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, and to commercialize ZTlido (lidocaine topical system) 1.8% for the treatment of post-herpetic neuralgia. RTX has completed a Phase 1B trial for intractable pain associated with cancer and a Phase 1B trial in osteoarthritis patients. SEMDEXA is in a pivotal Phase 3 trial for the treatment of lumbosacral radicular pain, or sciatica. ZTlido was approved by the FDA on
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