Therapy knowledge had been analyzed from 3,276 circumstances of sufferers with newly identified EGFR mutant NSCLC from Guardant Well being (NASDAQ:)
Analyses of sufferers with non-classical EGFR mutations reveal that almost all obtain frontline chemotherapy and the rest are handled with osimertinib or afatinib
Brief time to remedy discontinuation starting from 4 to eight months demonstrates clear unmet want for sufferers with non-classical EGFR mutant NSCLC
CAMBRIDGE, Mass., Sept. 14, 2024 (GLOBE NEWSWIRE) — Black Diamond Therapeutics, Inc. (Nasdaq: NASDAQ:), a clinical-stage oncology firm creating MasterKey therapies that focus on households of oncogenic mutations in sufferers with most cancers, in the present day introduced a poster analyzing real-world remedy outcomes for newly identified non-small cell lung most cancers (NSCLC) sufferers with non-classical EGFR mutations (NCMs) on the European Society for Medical Oncology (ESMO) Congress 2024 happening September 13-17, in Barcelona, Spain.
Of 11,434 sequenced circumstances of newly identified and treatment-naïve EGFRm NSCLC throughout the Guardant Well being (GuardantINFORM™) clinical-genomic database, first-line remedy info was accessible and evaluated for 3,276 sufferers. Outcomes revealed the presence of a broad spectrum of NCMs, together with P-loop and αC-helix compressing (PACC) mutations, and allowed correlation with real-world remedy practices and therapeutic outcomes. Findings additional demonstrated that present remedy practices for sufferers with NCMs are heterogenous: 36% of sufferers acquired osimertinib or afatinib and 60% of sufferers acquired chemotherapy and/or immunotherapy.
There’s a rising unmet want for brand new therapies for newly identified NSCLC sufferers with PACC and different non-classical EGFR mutations, mentioned John Heymach, M.D., Ph.D., Chair of Thoracic/Head and Neck Medical Oncology at MD Anderson Most cancers Heart. Actual-world remedy outcomes present that present EGFR TKIs present little profit to those sufferers, and chemotherapy brings vital toxicity, administration burden, and restricted efficacy.
Newly identified sufferers expressing NCMs discontinued osimertinib remedy at a median of 6.0 months versus sufferers expressing classical mutations, who remained on remedy for 13.8 months. Sufferers receiving afatinib discontinued remedy at a median of 8.0 months, and the median time to remedy discontinuation for sufferers on chemotherapy was 4.2 months.
BDTX-1535 was designed to deal with a broad spectrum of EGFR mutations, with emphasis on non-classical mutations that reach past PACC mutations, mentioned Elizabeth Buck, Ph.D., Chief Scientific Officer and co-founder of Black Diamond Therapeutics. BDTX-1535 is probably the most superior fourth- technology EGFR TKI in scientific improvement to deal with this underserved affected person inhabitants.
The brand new real-world outcomes construct upon findings introduced on the 2024 American Affiliation of Most cancers Analysis (AACR) Annual Assembly across the evolving EGFR mutation panorama in NSCLC that exposed greater than 100 NCMs, which might be current in 20-30% of newly identified sufferers. Black Diamond plans to reveal preliminary Part 2 knowledge in Q1 2025 within the first-line NCM setting. The corporate additionally plans to launch preliminary Part 2 ends in the second/third-line setting later this month.
About Black Diamond Therapeutics
Black Diamond Therapeutics is a clinical-stage oncology firm creating MasterKey therapies that focus on households of oncogenic mutations in sufferers with most cancers. The Firm’s MasterKey therapies are designed to deal with a broad spectrum of genetically outlined tumors, overcome resistance, reduce wild-type mediated toxicities, and be mind penetrant to deal with CNS illness. The Firm is advancing two clinical-stage packages: BDTX-1535, a brain-penetrant fourth-generation EGFR MasterKey inhibitor concentrating on EGFR mutant NSCLC and GBM, and BDTX-4933, a brain-penetrant RAF MasterKey inhibitor concentrating on KRAS, NRAS and BRAF alterations in stable tumors. For extra info, please go to www.blackdiamondtherapeutics.com.
Ahead-Trying Statements
Statements contained on this press release concerning issues that aren’t historic details are forward-looking statements throughout the which means of the Personal Securities Litigation Reform Act of 1995. As a result of such statements are topic to dangers and uncertainties, precise outcomes could differ materially from these expressed or implied by such forward-looking statements. Such statements embody, however aren’t restricted to, statements concerning: the unmet want for brand new therapies for newly identified NSCLC sufferers with non-classical EGFR mutations and the potential of BDTX-1535 to deal with this unmet medical want and profit sufferers with NSCLC throughout a number of traces of remedy, the continued improvement and development of BDTX-1535, together with the continued scientific trial and the timing of scientific updates for BDTX-1535 in sufferers with NSCLC, and potential future improvement plans for BDTX-1535 in NSCLC. Any forward-looking statements on this press release are primarily based on administration’s present expectations of future occasions and are topic to numerous dangers and uncertainties that would trigger precise outcomes to vary materially and adversely from these set forth in or implied by such forward-looking statements. Dangers that contribute to the unsure nature of the forward-looking statements embody these dangers and uncertainties set forth in its Annual Report on Kind 10-Okay for the yr ended December 31, 2023, filed with the US Securities and Trade Fee and in its subsequent filings filed with the US Securities and Trade Fee. All forward-looking statements contained on this press release converse solely as of the date on which they had been made. The Firm undertakes no obligation to replace such statements to mirror occasions that happen or circumstances that exist after the date on which they had been made.
Contacts
For Buyers:
Mario Corso, Head of Investor Relations, Black Diamond Therapeutics
mcorso@bdtx.com
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