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.
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.
About Sorrento Therapeutics, Inc.
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
February 28, 2018.
For more information visit
www.sorrentotherapeutics.com.
Forward-Looking Statements
This press release and any statements made for
and during any presentation or meeting contain forward-looking
statements related to Sorrento Therapeutics, Inc., under the safe
harbor provisions of Section 21E of the Private Securities
Litigation Reform Act of 1995 and subject to risks and
uncertainties that could cause actual results to differ materially
from those projected. Forward-looking statements include statements
regarding abivertinib, including the potential safety and clinical
benefits thereof; the efficacy of abivertinib in advanced and
heavily pretreated patients with non-small cell lung cancer; the
potential for data results to be replicated or continue to show
improved clinical safety or efficacy; and Sorrento’s plans to
request a pre-NDA meeting for abivertinib. Risks and uncertainties
that could cause our actual results to differ materially and
adversely from those expressed in our forward-looking statements,
include, but are not limited to: risks related to Sorrento's
technologies and prospects, including, but not limited to risks
related to seeking regulatory approval for abivertinib; clinical
development risks, including risks in the progress, timing, cost,
and results of clinical trials and product development programs;
risk of difficulties or delays in obtaining regulatory approvals;
risks that clinical study results may not meet any or all endpoints
of a clinical study and that any data generated from such studies
may not support a regulatory submission or approval; risks that
prior test, study and trial results may not be replicated in future
studies and trials; risks of manufacturing and supplying drug
product; risks related to leveraging the expertise of its
employees, subsidiaries, affiliates and partners to assist Sorrento
in the execution of its therapeutic antibody product candidate
strategies; risks related to the global impact of COVID-19; and
other risks that are described in Sorrento's most recent periodic
reports filed with the Securities and Exchange Commission,
including Sorrento's Annual Report on Form 10-K for the year ended
December 31, 2020, and subsequent Quarterly Reports on Form 10-Q
filed with the Securities and Exchange Commission, including the
risk factors set forth in those filings. Investors are cautioned
not to place undue reliance on these forward-looking statements,
which speak only as of the date of this release and we undertake no
obligation to update any forward-looking statement in this press
release except as required by law.
Media and Investor Relations
ContactDorman FollowwillEmail:
mediarelations@sorrentotherapeutics.com
Sorrento® and the Sorrento logo are registered
trademarks of Sorrento Therapeutics, Inc.
G-MAB™, DAR-T™, SOFUSA™, COVIGUARD™, COVI-AMG™,
COVISHIELD™, COVIDROPS™, COVI-MSC™, COVITRACK™, COVITRACE™ and
COVISTIX™ are trademarks of Sorrento Therapeutics, Inc.
SEMDEXA™ is a trademark of Semnur
Pharmaceuticals, Inc.
ZTlido® is a registered trademark owned by
Scilex Pharmaceuticals Inc.
All other trademarks are the property of their
respective owners.
©2021 Sorrento Therapeutics, Inc. All Rights
Reserved.
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