Black Diamond Therapeutics Presents Novel Real-World Evidence of the Evolving EGFR Mutation Landscape in NSCLC and the Opportunity for BDTX-1535 in an Oral Presentation at the 2024 American Association of Cancer Research Annual Meeting
April 07 2024 - 5:00PM
Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a
clinical-stage oncology company developing MasterKey therapies that
target families of oncogenic mutations in patients with cancer,
presented real-world evidence of the evolving epidermal growth
factor receptor (EGFR) mutation landscape in non-small cell lung
cancer (NSCLC), and the potential of BDTX-1535 to address a broader
range of mutations compared to existing therapies. The results were
disclosed in an oral presentation on April 7, 2024, at the 2024
American Association of Cancer Research (AACR) Annual Meeting held
in San Diego, California.
The oral presentation, titled “BDTX-1535 – A MasterKey EGFR
Inhibitor Targeting Classical, Non-Classical and the C797S
Resistance Mutation to Address the Evolved Landscape of EGFR Mutant
NSCLC,” evaluated more than 235,000 sequenced cases of NSCLC
sourced from Guardant Health (GuardantINFORM™) and Foundation
Medicine (FoundationInsights™). The analyses reveal a broad
spectrum of non-classical mutations, as well as an increased
prevalence of the acquired resistance mutation, C797S. Over 100
unique non-classical EGFR oncogenic driver mutations were
identified in newly diagnosed patients with NSCLC, and these
non-classical EGFR mutations were present in 20-30% of patients
across all lines of treatment.
“The landscape of EGFR mutations in NSCLC continues to evolve,
revealing classical and non-classical driver mutations,” said John
Heymach, M.D., Ph.D., Chair of Thoracic/Head and Neck Medical
Oncology at MD Anderson Cancer Center. “Non-classical mutations
fall into categories including kinase domain PACC mutations and
ectodomain mutations; therefore, next generation EGFR targeted
therapies must effectively cover multiple subgroups of
mutations.”
“Novel targeted therapies are still needed to continue to
improve clinical outcomes for patients with EGFR-mutant lung
cancers,” added Xiuning Le, M.D., Ph.D., Associate Professor,
Thoracic/Head and Neck Medical Oncology at MD Anderson Cancer
Center. “To extend survival for our patients, newer drugs need to
have good mutational coverage, good tolerability, and good brain
penetrance.”
Preclinical data demonstrated that BDTX-1535 potently inhibits
more than 50 clinically relevant, non-classical EGFR mutations (as
well as the classical L858R and exon19-del mutations) while sparing
wild-type EGFR. The compound also potently inhibits the drug
resistance C797S mutation, which emerges following treatment with
third-generation EGFR inhibitors, including osimertinib. Real-world
data indicate non-classical EGFR mutations can be co-expressed with
classical mutation L858R, a setting that has been characterized by
shorter duration of response to osimertinib first-line therapy.
Preclinical data show that BDTX-1535 potently inhibits these
co-expressed non-classical mutations.
“BDTX-1535 was designed to address a broad spectrum of more than
50 non-classical oncogenic EGFR mutations, as well as the C797S
resistance mutation,” said Elizabeth Buck, Ph.D., Chief Scientific
Officer and co-founder of Black Diamond Therapeutics. “We believe
that the potency of BDTX-1535 against the full spectrum of
classical, non-classical, and C797S mutations positions the
compound as the first and best-in-class fourth-generation EGFR
inhibitor potentially offering NSCLC patients a well-tolerated,
brain-penetrant, oral therapy across various lines of
treatment.”
Phase 1 proof-of-concept data demonstrating durable responses in
recurrent NSCLC patients with both non-classical and acquired
resistance C797S mutations were presented in October 2023. Black
Diamond is currently advancing BDTX-1535 in a Phase 2 trial for
patients with EGFRm NSCLC across multiple lines of therapy.
Patients are being enrolled both in a first-line (1L) setting (for
those expressing EGFR non-classical mutations) and in second- and
third-line (2L/3L) settings following prior treatment with an EGFR
inhibitor. Initial results from 2L/3L patients are anticipated in
the third quarter of 2024.
About BDTX-1535BDTX-1535 is an oral,
brain-penetrant MasterKey inhibitor of oncogenic epidermal growth
factor receptor (EGFR) mutations in non-small cell lung cancer
(NSCLC), including classical driver mutations, non-classical driver
mutations, and the acquired resistance C797S mutation. BDTX-1535 is
a fourth-generation tyrosine kinase inhibitor (TKI) that potently
inhibits, based on preclinical data, more than 50 oncogenic EGFR
mutations expressed across a diverse group of patients with NSCLC
in multiple lines of therapy. Based on preclinical data, BDTX-1535
also inhibits EGFR extracellular domain mutations and alterations
commonly expressed in glioblastoma (GBM) and avoids paradoxical
activation observed with earlier generation reversible TKIs. A
“window of opportunity” trial of BDTX-1535 in patients with GBM is
ongoing (NCT06072586) and a Phase 2 trial is ongoing in patients
with NSCLC (NCT05256290).
About Black Diamond TherapeuticsBlack Diamond
Therapeutics is a clinical-stage oncology company focused on the
development of MasterKey therapies that address families of
oncogenic mutations in clinically validated targets. The Company’s
MasterKey therapies are designed to address broad genetically
defined patient populations, overcome resistance, minimize
wild-type mediated toxicities, and be brain penetrant to treat CNS
disease. The Company is advancing two clinical-stage programs:
BDTX-1535, a brain-penetrant fourth-generation EGFR MasterKey
inhibitor targeting EGFR mutant NSCLC and GBM, and BDTX-4933, a
brain-penetrant RAF MasterKey inhibitor targeting KRAS, NRAS and
BRAF alterations in solid tumors. For more information, please
visit www.blackdiamondtherapeutics.com.
Forward-Looking StatementsStatements contained
in this press release regarding matters that are not historical
facts are “forward-looking statements” within the meaning of the
Private Securities Litigation Reform Act of 1995. Because such
statements are subject to risks and uncertainties, actual results
may differ materially from those expressed or implied by such
forward-looking statements. Such statements include, but are not
limited to, statements regarding: the potential of BDTX-1535 to
address a broader range of mutations compared to existing
therapies, the position of BDTX-1535 as compared to other
fourth-generation EGFR inhibitors, the timing of clinical
updates for BDTX-1535 in patients with NSCLC and in patients with
recurrent GBM, and the potential of BDTX-1535 to benefit patients
with NSCLC. Any forward-looking statements in this statement are
based on management’s current expectations of future events and are
subject to a number of risks and uncertainties that could cause
actual results to differ materially and adversely from those set
forth in or implied by such forward-looking statements. Risks that
contribute to the uncertain nature of the forward-looking
statements include those risks and uncertainties set forth in its
Annual Report on Form 10-K for the year ended December 31, 2023,
filed with the United States Securities and Exchange Commission and
in its subsequent filings filed with the United States Securities
and Exchange Commission. All forward-looking statements contained
in this press release speak only as of the date on which they were
made. The Company undertakes no obligation to update such
statements to reflect events that occur or circumstances that exist
after the date on which they were made.
ContactsFor Investors:Mario Corso, Head of
Investor Relations, Black Diamond Therapeuticsmcorso@bdtx.com
For Media:media@bdtx.com
Black Diamond Therapeutics (NASDAQ:BDTX)
Historical Stock Chart
From Apr 2024 to May 2024
Black Diamond Therapeutics (NASDAQ:BDTX)
Historical Stock Chart
From May 2023 to May 2024