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Black Diamond Therapeutics (Nasdaq: BDTX) presented real-world treatment outcomes for newly diagnosed NSCLC patients with non-classical EGFR mutations (NCMs) at the ESMO Congress 2024. The study analyzed 3,276 cases from Guardant Health’s database, revealing that 60% of NCM patients received chemotherapy/immunotherapy, while 36% received osimertinib or afatinib. Patients with NCMs showed shorter treatment duration compared to those with classical mutations. BDTX-1535, Black Diamond’s fourth-generation EGFR TKI, aims to address a broad spectrum of EGFR mutations, including NCMs. The company plans to disclose initial Phase 2 data for BDTX-1535 in Q1 2025 for first-line NCM treatment and release second/third-line results later this month.
Black Diamond Therapeutics (Nasdaq: BDTX) ha presentato i risultati di trattamento nel mondo reale per pazienti con NSCLC recentemente diagnosticati, affetti da mutazioni EGFR non classiche (NCM), durante il Congresso ESMO 2024. Lo studio ha analizzato 3.276 casi dal database di Guardant Health, rivelando che il 60% dei pazienti con NCM ha ricevuto chemioterapia/immunoterapia, mentre il 36% ha ricevuto osimertinib o afatinib. I pazienti con NCM hanno mostrato una durata del trattamento più breve rispetto a quelli con mutazioni classiche. BDTX-1535, il TKI EGFR di quarta generazione di Black Diamond, mira a trattare un ampio spettro di mutazioni EGFR, comprese le NCM. L’azienda prevede di rivelare i dati iniziali del Fase 2 per BDTX-1535 nel primo trimestre del 2025 per il trattamento di NCM in prima linea e di pubblicare i risultati di seconda/terza linea entro la fine di questo mese.
Black Diamond Therapeutics (Nasdaq: BDTX) presentó los resultados del tratamiento en el mundo real para pacientes recién diagnosticados con NSCLC que tienen mutaciones EGFR no clásicas (NCM) en el Congreso ESMO 2024. El estudio analizó 3,276 casos de la base de datos de Guardant Health, revelando que el 60% de los pacientes con NCM recibieron quimioterapia/inmunoterapia, mientras que el 36% recibió osimertinib o afatinib. Los pacientes con NCM mostraron una menor duración del tratamiento en comparación con aquellos con mutaciones clásicas. BDTX-1535, el TKI EGFR de cuarta generación de Black Diamond, busca abordar un amplio espectro de mutaciones EGFR, incluidas las NCM. La compañía planea divulgar los datos iniciales de Fase 2 para BDTX-1535 en el primer trimestre de 2025 para el tratamiento de NCM de primera línea y lanzar los resultados de segunda/tercera línea a finales de este mes.
블랙 다이아몬드 테라퓨틱스(나스닥: BDTX)가 ESMO Congress 2024에서 비전형 EGFR 변이(NCM)를 가진 새로 진단된 NSCLC 환자에 대한 실제 치료 결과를 발표했습니다. 이 연구는 Guardant Health의 데이터베이스에서 3,276건의 사례를 분석하여 NCM 환자의 60%가 화학요법/면역요법을 받았고, 36%가 오시머티닙 또는 아파티닙을 받았음을 밝혔습니다. NCM 환자는 전형적인 변이를 가진 환자에 비해 치료 기간이 짧았습니다. 블랙 다이아몬드의 4세대 EGFR TKI인 BDTX-1535는 NCM을 포함한 다양한 EGFR 변이를 다루는 것을 목표로 합니다. 이 회사는 2025년 1분기에 NCM 1차 치료를 위한 BDTX-1535의 초기 2상 데이터를 공개할 계획이며, 이달 말에 2차/3차 결과를 발표할 예정입니다.
Black Diamond Therapeutics (Nasdaq: BDTX) a présenté les résultats de traitement du monde réel pour les patients nouvellement diagnostiqués atteints de NSCLC présentant des mutations EGFR non classiques (NCM) lors du Congrès ESMO 2024. L’étude a analysé 3 276 cas à partir de la base de données de Guardant Health, révélant que 60% des patients NCM ont reçu une chimiothérapie/immunothérapie, tandis que 36% ont reçu de l’osimertinib ou de l’afatinib. Les patients présentant des NCM ont montré une durée de traitement plus courte par rapport à ceux ayant des mutations classiques. BDTX-1535, le TKI EGFR de quatrième génération de Black Diamond, vise à traiter un large éventail de mutations EGFR, y compris les NCM. La société prévoit de divulguer des données initiales de Phase 2 pour BDTX-1535 au premier trimestre 2025 pour le traitement NCM de première ligne et de publier les résultats de la deuxième/troisième ligne plus tard ce mois-ci.
Black Diamond Therapeutics (Nasdaq: BDTX) hat auf dem ESMO Kongress 2024 die Behandlungsergebnisse aus der realen Welt für neu diagnostizierte NSCLC-Patienten mit nicht klassischen EGFR-Mutationen (NCMs) vorgestellt. Die Studie analysierte 3.276 Fälle aus der Datenbank von Guardant Health und zeigte, dass 60% der NCM-Patienten Chemotherapie/Immuntherapie erhielten, während 36% Osimertinib oder Afatinib erhielten. Patienten mit NCMs hatten eine kürzere Behandlungsdauer im Vergleich zu denen mit klassischen Mutationen. BDTX-1535, der EGFR TKI der vierten Generation von Black Diamond, zielt darauf ab, ein breites Spektrum von EGFR-Mutationen, einschließlich NCMs, zu adressieren. Das Unternehmen plant, im ersten Quartal 2025 die initialen Phase 2-Daten für BDTX-1535 zur Erstanwendung bei NCM zu veröffentlicht und die Ergebnisse der zweiten/dritten Linie noch in diesem Monat bekannt zu geben.
Positive
- BDTX-1535 is the most advanced fourth-generation EGFR TKI in clinical development for non-classical EGFR mutations
- Black Diamond plans to disclose initial Phase 2 data for BDTX-1535 in Q1 2025 for first-line NCM treatment
- The company will release initial Phase 2 results for second/third-line treatment later this month
Negative
- Current treatments for non-classical EGFR mutations show efficacy, with short median time to treatment discontinuation (4-8 months)
- Patients with non-classical mutations discontinued osimertinib therapy much earlier (6.0 months) compared to those with classical mutations (13.8 months)
This real-world data analysis reveals critical insights into the treatment landscape for NSCLC patients with non-classical EGFR mutations (NCMs). The study, involving 3,276 patients, highlights a significant unmet medical need. Key findings include:
- Heterogeneous treatment practices: 36% received osimertinib/afatinib, while 60% received chemo/immunotherapy
- Short median time to treatment discontinuation: 6.0 months for osimertinib in NCM patients vs. 13.8 months for classical mutations
- Even shorter durations for afatinib (8.0 months) and chemotherapy (4.2 months)
These results underscore the urgent need for more effective therapies targeting NCMs in NSCLC, potentially opening a significant market opportunity for novel treatments like BDTX-1535.
The presentation at ESMO 2024 sheds light on a critical gap in NSCLC treatment. The prevalence of non-classical EGFR mutations (NCMs) in 20-30% of newly diagnosed patients, coupled with poor outcomes on current therapies, represents a substantial unmet need. The short duration of benefit from existing treatments is alarming:
- Osimertinib: 6.0 months for NCMs vs. 13.8 months for classical mutations
- Afatinib: 8.0 months
- Chemotherapy: mere 4.2 months
These findings emphasize the urgent need for targeted therapies like BDTX-1535, potentially revolutionizing treatment for this underserved population. The upcoming Phase 2 data in Q1 2025 could be a game-changer if it demonstrates improved efficacy in NCM patients.
This real-world data presentation at ESMO 2024 positions Black Diamond Therapeutics favorably in the competitive NSCLC market. Key market implications include:
- Large addressable market: 20-30% of newly diagnosed NSCLC patients with NCMs
- Clear differentiation: BDTX-1535 as the most advanced 4th-gen EGFR TKI for NCMs
- Potential first-mover advantage in an underserved segment
- Near-term catalysts: Phase 2 data in Q1 2025 (first-line) and later this month (second/third-line)
The unmet need demonstrated by poor outcomes with current treatments creates a significant opportunity for BDTX-1535. If successful, it could capture a substantial market share and potentially become the standard of care for NCM NSCLC patients, driving considerable value for the company.
Treatment data were analyzed from 3,276 cases of patients with newly diagnosed EGFR mutant NSCLC from Guardant Health
Analyses of patients with non-classical EGFR mutations reveal that the majority receive frontline chemotherapy and the remainder are treated with osimertinib or afatinib
Short time to treatment discontinuation ranging from four to eight months demonstrates clear unmet need for patients with non-classical EGFR mutant NSCLC
CAMBRIDGE, Mass., Sept. 14, 2024 (GLOBE NEWSWIRE) — Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer, today presented a poster analyzing real-world treatment outcomes for newly diagnosed non-small cell lung cancer (NSCLC) patients with non-classical EGFR mutations (NCMs) at the European Society for Medical Oncology (ESMO) Congress 2024 taking place September 13-17, in Barcelona, Spain.
Of 11,434 sequenced cases of newly diagnosed and treatment-naïve EGFRm NSCLC within the Guardant Health (GuardantINFORM™) clinical-genomic database, first-line treatment information was available and evaluated for 3,276 patients. Results revealed the presence of a broad spectrum of NCMs, including P-loop and αC-helix compressing (PACC) mutations, and allowed correlation with real-world treatment practices and therapeutic outcomes. Findings further demonstrated that current treatment practices for patients with NCMs are heterogenous: 36% of patients received osimertinib or afatinib and 60% of patients received chemotherapy and/or immunotherapy.
“There is a growing unmet need for new treatments for newly diagnosed NSCLC patients with PACC and other non-classical EGFR mutations,” said John Heymach, M.D., Ph.D., Chair of Thoracic/Head and Neck Medical Oncology at MD Anderson Cancer Center. “Real-world treatment outcomes show that current EGFR TKIs provide little benefit to these patients, and chemotherapy brings significant toxicity, administration burden, and limited efficacy.”
Newly diagnosed patients expressing NCMs discontinued osimertinib therapy at a median of 6.0 months versus patients expressing classical mutations, who remained on therapy for 13.8 months. Patients receiving afatinib discontinued therapy at a median of 8.0 months, and the median time to treatment discontinuation for patients on chemotherapy was 4.2 months.
“BDTX-1535 was designed to address a broad spectrum of EGFR mutations, with emphasis on non-classical mutations that extend beyond PACC mutations,” said Elizabeth Buck, Ph.D., Chief Scientific Officer and co-founder of Black Diamond Therapeutics. “BDTX-1535 is the most advanced fourth- generation EGFR TKI in clinical development to address this underserved patient population.”
The new real-world results build upon findings presented at the 2024 American Association of Cancer Research (AACR) Annual Meeting around the evolving EGFR mutation landscape in NSCLC that revealed more than 100 NCMs, which can be present in 20-30% of newly diagnosed patients. Black Diamond plans to disclose initial Phase 2 data in Q1 2025 in the first-line NCM setting. The company also plans to release initial Phase 2 results in the second/third-line setting later this month.
About Black Diamond Therapeutics
Black Diamond Therapeutics is a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer. The Company’s MasterKey therapies are designed to address a broad spectrum of genetically defined tumors, 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 Statements
Statements 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 unmet need for new treatments for newly diagnosed NSCLC patients with non-classical EGFR mutations and the potential of BDTX-1535 to address this unmet medical need and benefit patients with NSCLC across multiple lines of therapy, the continued development and advancement of BDTX-1535, including the ongoing clinical trial and the timing of clinical updates for BDTX-1535 in patients with NSCLC, and potential future development plans for BDTX-1535 in NSCLC. Any forward-looking statements in this press release 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.
Contacts
For Investors:
Mario Corso, Head of Investor Relations, Black Diamond Therapeutics
mcorso@bdtx.com
For Media:
media@bdtx.com
FAQ
What did Black Diamond Therapeutics present at ESMO Congress 2024?
Black Diamond Therapeutics presented real-world treatment outcomes for newly diagnosed NSCLC patients with non-classical EGFR mutations (NCMs) at the ESMO Congress 2024.
How many cases were analyzed in the Black Diamond Therapeutics NSCLC study?
The study analyzed treatment data from 3,276 cases of patients with newly diagnosed EGFR mutant NSCLC from the Guardant Health database.
What are the current treatment practices for NSCLC patients with non-classical EGFR mutations according to BDTX’s study?
According to the study, 60% of patients with non-classical EGFR mutations received chemotherapy and/or immunotherapy, while 36% received osimertinib or afatinib.
When will Black Diamond Therapeutics (BDTX) release Phase 2 data for BDTX-1535?
Black Diamond plans to disclose initial Phase 2 data for BDTX-1535 in Q1 2025 for first-line non-classical mutation treatment and release second/third-line results later this month.
