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

On April 21, 2026 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer, reported multiple presentations at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from May 29 – June 2, 2026, in Chicago.

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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.

(Press release, Black Diamond Therapeutics, APR 21, 2026, View Source [SID1234664601])

Bicycle Therapeutics Announces Oral and Poster Presentations at the 2026 ASCO Annual Meeting

On April 21, 2026 Bicycle Therapeutics plc (NASDAQ: BCYC), a pharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported an oral presentation and multiple poster presentations across five abstracts at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2026 Annual Meeting, taking place May 29–June 2 in Chicago.

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Presentation Details:

Title: Interim analysis results from Duravelo-2: Zelenectide pevedotin (zele; BT8009) + pembrolizumab in patients (pts) with previously untreated locally advanced/metastatic urothelial carcinoma (la/mUC)
Type: Rapid Oral Abstract Session
Session: Genitourinary Cancer – Kidney and Bladder
Date and Time: Monday, June 1, 8:30-8:36 a.m. CT
Abstract Number: 4516
Lead Author: Yohann Loriot, M.D., Institute Gustave Roussy

Title: Interim analysis results from Duravelo-2: zelenectide pevedotin (zele; BT8009) in patients (pts) with previously treated locally advanced/metastatic urothelial carcinoma (la/mUC)
Type: Poster Session
Session: Genitourinary Cancer – Kidney and Bladder
Date and Time: Sunday, May 31, 9 a.m.-12 p.m. CT
Abstract Number: 4566
Lead Author: Dan Petrylak, M.D., Yale School of Medicine

Title: Zelenectide pevedotin (BT8009) monotherapy in previously treated metastatic urothelial carcinoma (mUC): Update on Duravelo-1
Type: Poster Session
Session: Genitourinary Cancer – Kidney and Bladder
Date and Time: Sunday, May 31, 9 a.m.-12 p.m. CT
Abstract Number: 4563
Lead Author: Oscar Reig Torras, M.D., Hospital Clínic de Barcelona

Title: Zelenectide pevedotin (BT8009) plus pembrolizumab in 1L cisplatin-ineligible locally advanced/metastatic urothelial carcinoma: Update on Duravelo-1 B7
Type: Poster Session
Session: Genitourinary Cancer – Kidney and Bladder
Date and Time: Sunday, May 31, 9 a.m.-12 p.m. CT
Abstract Number: 4564
Lead Author: Ignacio Duran, M.D., Hospital Universitario Marqués de Valdecilla

Title: Identify optimized dosage for zelenectide pevedotin in locally advanced/metastatic urothelial carcinoma (la/mUC) using quantitative analyses
Type: Poster Session
Session: Genitourinary Cancer – Kidney and Bladder
Date and Time: Sunday, May 31, 9 a.m.-12 p.m. CT
Abstract Number: 4567
Lead Author: Yasong Lu, Ph.D., Bicycle Therapeutics

The presentations will be made available in the Publications section of the Bicycle Therapeutics website on the morning of each session.

(Press release, Bicycle Therapeutics, APR 21, 2026, View Source [SID1234664600])

Avenzo Therapeutics to Present Updated Results from the Phase 1 Study of AVZO-021, a Potential Best-in-Class CDK2 Inhibitor, at the 2026 American Society of Clinical Oncology Annual Meeting

On April 21, 2026 Avenzo Therapeutics, Inc. ("Avenzo"), a clinical-stage biotechnology company developing next-generation oncology therapies, reported the acceptance of an abstract for poster presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place in Chicago, Illinois from May 29 – June 2, 2026.

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Avenzo will present updated safety and efficacy results from the Phase 1 portion of its ongoing Phase 1/2 clinical study of AVZO-021, its potential best-in-class cyclin-dependent kinase 2 (CDK2) selective inhibitor.

Details of the poster presentation are as follows:

Abstract: 1094

Title: A phase 1/2, first-in-human study of AVZO-021, a selective cyclin-dependent kinase 2 inhibitor (CDK2i), as monotherapy and in combination for patients with advanced solid tumors, including hormone receptor–positive (HR+)/human epidermal growth factor receptor 2–negative (HER2−) breast cancer (BC) and cyclin E1 (CCNE1)–amplified solid tumors: Updated safety and efficacy results.

Session Title: Breast Cancer—Metastatic

Poster Board: 208

Date and Time: June 1, 2026, 1:30 to 4:30 p.m. CT

(Press release, Avenzo Therapeutics, APR 21, 2026, View Source [SID1234664599])

Aulos Bioscience Announces Presentation of Promising Phase 1/2 Data for Imneskibart in Melanoma at 2026 ASCO Annual Meeting

On April 21, 2026 AulosTM Bioscience, an immuno-oncology company working to revolutionize cancer care through development of its lead immune-activating antibody therapeutic imneskibart (AU-007), reported that new Phase 1/2 data from its ongoing study of imneskibart will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2026 Annual Meeting. The presentation will focus on promising results for imneskibart with and without nivolumab in checkpoint inhibitor (CPI)-refractory cutaneous melanoma. The ASCO (Free ASCO Whitepaper) Annual Meeting is being held online and in Chicago, Illinois, from May 29–June 2, 2026.

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Details of the poster presentation are as follows:

Poster Title: Imneskibart + low-dose subcutaneous IL-2 ± nivolumab in patients with CPI-refractory cutaneous melanoma: Promising results from an ongoing phase 1/2 study
Abstract: 9526
Session Type/Title: Poster Session – Melanoma/Skin Cancers
Session Date and Time: Sunday, May 31, 2026, 9:00 a.m.-12:00 p.m. CDT

The poster will be presented in the Exhibit Hall at McCormick Place. An electronic version will also be available on the ASCO (Free ASCO Whitepaper) 2026 online meeting platform.

About Imneskibart
Imneskibart (AU-007) is a human IgG1 monoclonal antibody designed by leveraging artificial intelligence that is highly selective to the CD25-binding portion of IL-2. With a mechanism of action unlike any other IL-2 therapeutic in development, imneskibart redirects IL-2 to reinforce anti-tumor immune effects. This is achieved by preventing IL-2, either exogenous or secreted by effector T cells, from binding to trimeric receptors on regulatory T cells while still allowing IL-2 to bind and expand effector T cells and NK cells. This prevents the negative feedback loop caused by other IL-2-based treatments and biases the immune system toward activation over suppression. Imneskibart also prevents IL-2 from binding to CD25-containing receptors on eosinophils, as well as vasculature and pulmonary endothelium, which may significantly reduce the vascular leak syndrome and pulmonary edema associated with high-dose IL-2 therapy.

To learn more about the imneskibart Phase 1/2 clinical trial program, including study locations in the United States and Australia, please visit ClinicalTrials.gov (identifier: NCT05267626), www.solidtumorstudy.com (U.S.) and www.solidtumourstudy.com (Australia).

(Press release, Aulos Bioscience, APR 21, 2026, View Source [SID1234664598])

Aprea Therapeutics to Provide Clinical Update on ACESOT-1051 Phase 1 Trial Evaluating WEE1 Inhibitor, APR-1051, at ASCO 2026 Annual Meeting

On April 21, 2026 Aprea Therapeutics, Inc. (Nasdaq: APRE) ("Aprea", or the "Company"), a clinical-stage precision medicine oncology company focused on the discovery and development of targeted therapies for patients with biomarker-defined cancers, reported the acceptance of an abstract "Early results from the first-in-human phase 1 study of WEE1 inhibitor APR-1051 in patients with advanced solid tumors (ACESOT-1051)" at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to take place May 29 – June 2, 2026, in Chicago, IL.

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Presentation Details:
Title: Early results from the first-in-human phase 1 study of WEE1 inhibitor APR-1051 in patients with advanced solid tumors (ACESOT-1051)
Presenting author: Shiraj Sen, MD. PhD., NEXT Oncology Dallas, TX
Session: Poster Session – Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Date and Time: May 30, 2026, 1:30 PM-4:30 PM CDT
Poster Board: 244


For more information on the ACESOT-1051 trial, refer to ClinicalTrials.gov NCT06260514.

(Press release, Aprea, APR 21, 2026, View Source [SID1234664597])