Press Releases April 21, 2026 04:01 PM

Olema Oncology to Present Initial Clinical Data for OP-3136 at the 2026 ASCO Annual Meeting

Olema Oncology to present promising initial clinical data for OP-3136 at ASCO 2026 alongside Phase 3 trial updates

By Sofia Navarro OLMA
Olema Oncology to Present Initial Clinical Data for OP-3136 at the 2026 ASCO Annual Meeting
OLMA

Olema Oncology announced it will present initial Phase 1 clinical data for its investigational drug OP-3136, a novel selective KAT6A/B inhibitor, at the 2026 ASCO Annual Meeting. The company will also provide updates on its ongoing Phase 3 OPERA-02 trial involving palazestrant plus ribociclib for advanced breast cancer. OP-3136 shows potent anti-proliferative activity and potential synergy with endocrine therapies, while palazestrant continues to advance as a key candidate for ER+/HER2- breast cancer treatment. These developments highlight Olema's focus on advancing novel therapies in the breast cancer treatment landscape.

Key Points

  • Olema to present preliminary Phase 1 data on OP-3136, a novel KAT6 inhibitor targeting advanced solid tumors and ER+/HER2- breast cancer, indicating progress in early-stage clinical development.
  • Updates scheduled for the Phase 3 OPERA-02 trial evaluating palazestrant combined with ribociclib as first-line treatment for ER+/HER2- advanced breast cancer.
  • Palazestrant possesses dual activity as a complete estrogen receptor antagonist and selective estrogen receptor degrader, with FDA Fast Track designation and ongoing pivotal Phase 3 trials, underscoring its potential clinical impact.

SAN FRANCISCO, April 21, 2026 (GLOBE NEWSWIRE) -- Olema Pharmaceuticals, Inc. (“Olema” or “Olema Oncology”, Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for breast cancer and beyond, today announced it will present initial clinical data from the Phase 1 study of OP-3136 in a poster presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 29-June 2 in Chicago, Illinois. The Company will also present a trial-in-progress poster for the Phase 3 OPERA-02 trial.

Poster Presentation Details
Title: A phase 1, first-in-human study of OP-3136, a novel oral selective KAT6A/B inhibitor, as monotherapy in advanced solid tumors and in combination with endocrine therapy in ER+, HER2− advanced breast cancer (ABC): Preliminary results
Abstract Number: 3088
Poster Number: 225
Date/Time: May 30, 2026 from 1:30pm-4:30pm CT / 2:30pm-5:30pm ET

Title: OPERA-02: A phase 3 study of palazestrant plus ribociclib as first-line treatment of ER+, HER2- advanced breast cancer
Abstract Number: TPS1152
Poster Number: 261b
Date/Time: June 1, 2026 from 1:30pm-4:30pm CT / 2:30pm-5:30pm ET

Additional information can be found on the ASCO Annual Meeting website.

About Olema Oncology
Olema Oncology is a clinical-stage biopharmaceutical company committed to transforming the standard of care and improving outcomes for patients living with breast cancer and beyond. Olema is advancing a pipeline of novel therapies by leveraging our deep understanding of endocrine-driven cancers, nuclear receptors, and mechanisms of acquired resistance. Our lead product candidate, palazestrant (OP-1250), is a proprietary, orally available complete estrogen receptor antagonist (CERAN) and a selective estrogen receptor degrader (SERD), currently in two Phase 3 clinical trials. In addition, Olema is developing OP-3136, a potent lysine acetyltransferase 6 (KAT6) inhibitor, now in a Phase 1 clinical study. Olema is headquartered in San Francisco and has operations in Cambridge, Massachusetts. For more information, please visit www.olema.com.

About Palazestrant (OP-1250)
Palazestrant (OP-1250) is a novel, orally available small molecule with dual activity as both a complete estrogen receptor antagonist (CERAN) and selective estrogen receptor degrader (SERD). It is currently being investigated in patients with recurrent, locally advanced or metastatic ER-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. In clinical studies, palazestrant completely blocks ER-driven transcriptional activity in both wild-type and mutant forms of metastatic ER+ breast cancer and has demonstrated anti-tumor efficacy along with attractive pharmacokinetics and exposure, favorable tolerability, central nervous system penetration, and combinability with cyclin-dependent kinase 4/6 (CDK4/6) inhibitors. Palazestrant has been granted U.S. Food and Drug Administration (FDA) Fast Track designation for the treatment of ER+/HER2- metastatic breast cancer that has progressed following one or more lines of endocrine therapy with at least one line given in combination with a CDK4/6 inhibitor. It is being evaluated as a single agent in the ongoing pivotal Phase 3 clinical trial, OPERA-01, and in combination with ribociclib in the ongoing pivotal Phase 3 clinical trial, OPERA-02. Palazestrant is also being evaluated in multiple Phase 1/2 studies in combination with ribociclib, palbociclib, alpelisib, everolimus, and atirmociclib.

About OP-3136
OP-3136 is a novel, orally available small molecule that potently and selectively inhibits lysine acetyltransferase 6 (KAT6), an epigenetic target that is dysregulated in breast and other cancers. In preclinical studies, OP-3136 has demonstrated significant anti-proliferative activity in ER+ breast cancer models and is combinable and synergistic with endocrine therapies including palazestrant and cyclin-dependent kinase 4/6 (CDK4/6) inhibitors. The Investigational New Drug (IND) application for OP-3136 was cleared by the U.S. Food and Drug Administration (FDA) in December 2024 and patients are currently enrolling in the Phase 1 clinical study.

Forward Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Words such as “anticipate,” “believe,” “could,” “expect,” “goal,” “intend,” “may,” “on track,” “potential,” “upcoming,” “will” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These statements include those related to the potential beneficial characteristics including but not limited to safety, tolerability, activity, efficacy and therapeutic effects of palazestrant or OP-3136 and the combinability of palazestrant or OP-3136 with other drugs. Because such statements deal with future events and are based on Olema’s current expectations, they are subject to various risks and uncertainties, and actual results, performance, or achievements of Olema could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including, without limitation, those discussed in the section titled “Risk Factors” in Olema’s Annual Report on Form 10-K for the year ended December 31, 2025, and future filings and reports that Olema makes from time to time with the U.S. Securities and Exchange Commission. Except as required by law, Olema assumes no obligation to update these forward-looking statements, including in the event that actual results differ materially from those anticipated in the forward-looking statements.

Media and Investor Relations Contact
Courtney O’Konek
Vice President, Corporate Communications
Olema Oncology
[email protected]


Risks

  • Clinical and regulatory risks inherent in early-stage drug development — OP-3136 is in Phase 1, and trial outcomes may not meet efficacy or safety expectations, impacting future prospects.
  • Potential competition and market adoption challenges for palazestrant and OP-3136 in a competitive breast cancer therapeutic landscape with existing CDK4/6 inhibitors and other endocrine therapies.
  • Uncertainties related to trial enrollment, data readouts, and regulatory approvals may affect the timing and likelihood of product commercialization, influencing Olema's financial performance.

More from Press Releases

Fiverr Announces First Quarter 2026 Results Apr 29, 2026 Nayax to Report 2026 Q1 Earnings on May 12, 2026 Apr 28, 2026 Xunlei Filed Its Annual Report on Form 20-F for Fiscal Year 2025 Apr 28, 2026 Mesoblast Achieves Patient Recruitment Target in Pivotal Phase 3 Trial for Chronic Low Back Pain Apr 28, 2026 Syntec Optics (Nasdaq: OPTX) Announces Pricing of $20 Million Underwritten Public Offering of Common Stock Apr 28, 2026