Black Diamond Therapeutics Announces Oral Presentation of Silevertinib Phase 2 Data in Frontline EGFRm NSCLC Patients at the 2026 ASCO Annual Meeting

Black Diamond Therapeutics (Nasdaq: BDTX) announced multiple presentations of Phase 2 silevertinib (BDTX-1535) data at the 2026 ASCO Annual Meeting, May 29–June 2, 2026 in Chicago.

Rhea-AI Summary

Black Diamond Therapeutics (Nasdaq: BDTX) announced multiple presentations of Phase 2 silevertinib (BDTX-1535) data at the 2026 ASCO Annual Meeting, May 29–June 2, 2026 in Chicago. An oral Rapid Abstract session on May 30, 2026 will feature frontline EGFRm NSCLC results; posters on May 31 and June 1 cover recurrent NSCLC and a randomized GBM trial.

Slides and posters will be made available on the company website at 8:00 AM EDT on the stated dates.

Argus Apr 21 session

+3.28% close to close Open Argus

Details

News Market Reaction – BDTX

On Apr 21, the day this news came out, BDTX closed 3.28% above the previous close.

Data tracked by StockTitan Argus for the Apr 21 session.

Key Figures

ASCO meeting dates: May 29 – June 2, 2026 Oral abstract number: 8519 Poster abstract number: 8620 +4 more

ASCO meeting dates

May 29 – June 2, 2026

2026 ASCO Annual Meeting schedule

Oral abstract number

8519

Frontline EGFRm NSCLC silevertinib Phase 2 oral presentation

Poster abstract number

8620

Previously treated EGFRm NSCLC silevertinib Phase 2 poster

GBM abstract number

TPS2098

Randomized Phase 2 GBM trial-in-progress poster

Oral session time

May 30, 2026, 1:15 PM–2:45 PM CDT

Frontline NSCLC silevertinib oral session

Poster session time

May 31, 2026, 9:00 AM–12:00 PM CDT

Previously treated NSCLC silevertinib poster

CNS tumors session time

June 1, 2026, 1:30 PM–4:30 PM CDT

Randomized GBM Phase 2 trial-in-progress poster

Previous Clinical trial Reports

4 past events · Latest: Dec 03

Same Type 4 events

1. Dec 03

   Phase 2 NSCLC/GBM data

   24h Move

   -22.0%

   Preliminary Phase 2 1L NSCLC data and randomized GBM trial plan for silevertinib.

2. Dec 02

   Phase 2 webcast notice

   24h Move

   -22.0%

   Announcement of webcast to present Phase 2 silevertinib trial results and update.

3. Sep 23

   Recurrent NSCLC data

   24h Move

   -5.5%

   Initial Phase 2 BDTX‑1535 data showing anti‑tumor activity in recurrent EGFRm NSCLC.

4. Jun 01

   GBM ASCO data

   24h Move

   -1.1%

   Promising Phase 1 BDTX‑1535 data in recurrent GBM presented at ASCO with good tolerability.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

phase 2, non-small cell lung cancer, egfr mutations, egfrviii-positive, +3 more

7 terms

phase 2 medical

"Safety and efficacy results of the phase 2 study of silevertinib (BDTX-1535)..."

Phase 2 is the mid-stage clinical trial where a new drug or treatment is tested in a larger group of patients to see if it works and to keep checking safety after initial human testing. Think of it as a field test that proves whether a product actually delivers its promised benefit. Investors watch Phase 2 closely because its results strongly influence a medicine’s chances of reaching the market, the size of its potential sales, and the company’s valuation.

non-small cell lung cancer medical

"patients with non-small cell lung cancer with non-classical EGFR mutations"

A broad category of lung tumors that grow from the cells lining the airways and make up the majority of lung cancer cases; it includes several subtypes that behave and respond to treatment differently, like different models of the same car family. It matters to investors because its large patient population and variety of treatment options — surgery, traditional chemo, targeted drugs and immunotherapies — create major markets where clinical trial results, drug approvals or changing treatment guidelines can quickly affect a company’s revenue and stock value.

egfr mutations medical

"non-small cell lung cancer with non-classical EGFR mutations"

EGFR mutations are changes in a gene that acts like a growth-control switch for certain cells; when the switch is altered it can cause abnormal cell growth that leads to some types of cancer. Investors care because these specific genetic changes determine which patients will benefit from targeted drugs, influence clinical trial success and regulatory approvals, and therefore shape demand, pricing potential, and the market size for therapies tied to those mutations.

egfrviii-positive medical

"newly diagnosed EGFRvIII-positive IDHwt MGMT unmethylated glioblastoma"

EGFRvIII-positive means cancer cells carry a specific mutated form of the EGFR protein, a cell-surface molecule that helps control cell growth; this particular variant (vIII) is not found on healthy cells. For investors it matters because the presence of this mutation can make a tumor eligible for specialized drugs or clinical trials and can change a therapy’s potential market and value—think of it as a unique fingerprint that lets a tailored drug fit only certain tumors.

glioblastoma medical

"EGFRvIII-positive IDHwt MGMT unmethylated glioblastoma"

Glioblastoma is a fast-growing and aggressive type of brain tumor that can affect a person's thinking, movement, or senses. Its seriousness and difficulty to treat can lead to significant health impacts, making it a concern for medical research and drug development. For investors, advances or setbacks in glioblastoma treatments can influence biotech companies and healthcare markets focused on cancer therapies.

temozolomide medical

"silevertinib in combination with temozolomide in newly diagnosed patients"

An oral chemotherapy drug that works by damaging the DNA of cancer cells so they can no longer grow and divide, most commonly used to treat certain brain tumors. For investors, temozolomide matters because clinical trial results, approvals, patent status, manufacturing supply and safety data can reshape a company’s drug revenue prospects and valuation—think of it as a key product in a biotech’s toolbox whose success or failure directly affects the business outlook.

mgmt unmethylated medical

"EGFRvIII-positive IDHwt MGMT unmethylated glioblastoma"

MGMT unmethylated means the DNA repair gene MGMT is not chemically silenced, so the cell keeps making the protein that fixes damage caused by certain DNA‑damaging chemotherapy drugs. For investors, this matters because tumors with an unmethylated MGMT often respond poorly to those standard therapies, affecting drug trial results, treatment choices and the market potential for drugs that must work around or target that active repair mechanism.

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• Poster also to be presented on the Phase 2 data of silevertinib in recurrent EGFRm NSCLC patients
• Trial-in-progress poster to be presented on the randomized Phase 2 trial of silevertinib in patients with newly diagnosed EGFRvIII-positive GBM

CAMBRIDGE, Mass., April 21, 2026 (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 announced multiple presentations at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting from May 29 – June 2, 2026, in Chicago.

Details for the Oral Presentation:

Session Type/Title: Rapid Oral Abstract Session - Lung Cancer—Non-Small Cell Metastatic
Title: Safety and efficacy results of the phase 2 study of silevertinib (BDTX-1535) in treatment-naïve patients with non-small cell lung cancer with non-classical EGFR mutations
Abstract: 8519
Presenter: Julia Rotow, MD, Dana-Farber Cancer Institute
Date and Time: May 30, 2026, 1:15 PM-2:45 PM CDT (slides will be available at 8:00 AM EDT on the Black Diamond website here)

Details for the Poster Presentations:

Session Type/Title: Poster Session - Lung Cancer—Non-Small Cell Metastatic
Title: Safety and efficacy results of the phase 2 study of silevertinib (BDTX-1535) in previously treated patients with non-small cell lung cancer with non-classical and C797S EGFR mutations
Abstract: 8620
Poster Board: 410
Presenter: Helena Yu, MD, Memorial Sloan Kettering Cancer Center
Date and Time: May 31, 2026, 9:00 AM-12:00 PM CDT

Session Type/Title: Poster Session - Central Nervous System Tumors
Title: Randomized phase 2 study to evaluate the efficacy and safety of silevertinib in combination with temozolomide in newly diagnosed patients with EGFRvIII-positive IDHwt MGMT unmethylated glioblastoma
Abstract: TPS2098
Poster Board: 460a
Presenter: Patrick Wen, MD, Dana-Farber Cancer Institute
Date and Time: June 1, 2026, 1:30 PM-4:30 PM CDT

Posters will become available on June 1, 2026 at 8:00 AM EDT on the Black Diamond Therapeutics website here.

About Silevertinib

Silevertinib is an oral, covalent, brain-penetrant fourth-generation tyrosine kinase inhibitor (TKI) that selectively targets classical and more than 50 non-classical EGFR mutations in NSCLC. It also potently inhibits key EGFR alterations seen in GBM, including EGFRvIII, while avoiding the paradoxical EGFR activation reported with reversible TKIs. To date, over 200 patients with EGFR‑mutant NSCLC or EGFR‑altered GBM have been treated with silevertinib.

In December 2025 the Company disclosed initial data from the Phase 2 trial of silevertinib in frontline NSCLC patients harboring a broad spectrum of non-classical EGFR mutations which demonstrated a 60% Objective Response Rate (ORR by RECIST 1.1), 86% CNS ORR (by RANO-BM) and 91% disease control rate as of a November 3, 2025 data cutoff. No new safety signals were observed.

The Company is also initiating a randomized Phase 2 trial of silevertinib in patients with newly diagnosed EGFRvIII-positive GBM in the second quarter of 2026.

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 central nervous system disease. The Company is advancing silevertinib, a brain-penetrant fourth-generation EGFR MasterKey inhibitor targeting EGFR-mutant NSCLC and GBM. For more information, please visit www.blackdiamondtherapeutics.com. 

From time to time, we may use our website or our LinkedIn profile at www.linkedin.com/company/black-diamond-therapeutics to distribute material information. Our financial and other material information is routinely posted to and accessible on the Investors section of our website, available at www.blackdiamondtherapeutics.com. Investors are encouraged to review the Investors section of our website because we may post material information on that site that is not otherwise disseminated by us. Information that is contained in and can be accessed through our website or our LinkedIn page is not incorporated into, and does not form a part of, this press release.

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 continued development and advancement of silevertinib, including the ongoing Phase 2 clinical trial and the timing of clinical updates for silevertinib in patients with NSCLC and in patients with GBM, expectations regarding the planned initiation of a randomized Phase 2 trial of silevertinib in patients with newly diagnosed EGFR-altered GBM, the potential of silevertinib to address the unmet medical need for newly diagnosed NSCLC patients with non-classical EGFR mutations and benefit patients with NSCLC across multiple lines of therapy, and the potential future development plans for silevertinib in NSCLC and GBM. 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, 2025, 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.

Contact
For Investors:
investors@bdtx.com

For Media:
media@bdtx.com

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

When will Black Diamond Therapeutics (BDTX) present silevertinib Phase 2 frontline EGFRm NSCLC data at ASCO 2026?

The oral presentation is scheduled for May 30, 2026, 1:15–2:45 PM CDT. According to the company, slides will be posted at 8:00 AM EDT on the company website the same day for investor review.

What data on recurrent EGFRm NSCLC will BDTX present at ASCO 2026 and when is the poster session?

A poster on previously treated EGFRm and C797S NSCLC is set for May 31, 2026, 9:00 AM–12:00 PM CDT. According to the company, the poster (Abstract 8620) will be available on the company website starting June 1, 2026 at 8:00 AM EDT.

Does BDTX present any glioblastoma (GBM) silevertinib data at ASCO 2026 and what trial is it?

Yes. A randomized Phase 2 trial combining silevertinib with temozolomide in newly diagnosed EGFRvIII-positive, IDHwt, MGMT unmethylated GBM will be presented as a poster on June 1, 2026. According to the company, the poster is Abstract TPS2098.

Who are the presenters for Black Diamond's ASCO 2026 silevertinib abstracts and their institutions?

Presenters include Julia Rotow, MD (Dana-Farber) for the oral session, Helena Yu, MD (Memorial Sloan Kettering) for the NSCLC poster, and Patrick Wen, MD (Dana-Farber) for the GBM poster, according to the company announcement.

Where and when will Black Diamond release ASCO 2026 slides and posters for BDTX-1535 silevertinib?

Slides for the oral presentation will be posted at 8:00 AM EDT on May 30, 2026, and posters at 8:00 AM EDT on June 1, 2026 on the company's website, according to the company.