On May 21, 2026 AstraZeneca reported its ambition to eliminate cancer as a cause of death and transform outcomes for people living with rare diseases with new data across its diverse, industry-leading portfolio and pipeline at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, 29 May to 2 June 2026.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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More than 85 abstracts will feature 10 approved and 13 potential new medicines from the Company, including 25 oral presentations. Highlights include:

EMERALD-3: Phase III trial of Imfinzi (durvalumab) in combination with Imjudo (tremelimumab), with or without lenvatinib, and transarterial chemoembolisation (TACE) in patients with unresectable hepatocellular carcinoma (HCC) eligible for embolisation (Oral Abstract #LBA4000).
CARES: Phase III clinical programme of anselamimab, a potential first-in-class anti-fibril therapy from Alexion, AstraZeneca Rare Disease, in newly diagnosed patients with light chain (AL) amyloidosis receiving standard of care for underlying plasma cell dyscrasia, including results from a prespecified subgroup analysis based on involved kappa (κ) or lambda (λ) free light chain (Oral Abstract #7501).
SERENA-6: Final progression-free survival 2 (PFS2) results and circulating tumour DNA (ctDNA) clearance data linked to longer-term efficacy outcomes from the SERENA-6 Phase III trial of camizestrant in combination with widely approved cyclin-dependent kinase (CDK) 4/6 inhibitors in the 1st-line treatment of patients with hormone receptor (HR)-positive, HER2-negative advanced breast cancer whose tumours have an emergent ESR1 mutation (Oral Abstract #LBA1007).
BLUESTAR: Updated safety and efficacy results from the BLUESTAR Ph I/IIa trial of the B7-H4-directed ADC puxitatug samrotecan (Puxi-Sam) in patients with relapsed/metastatic B7-H4-positive endometrial and ovarian cancer who progressed on prior standard-of-care therapy (Rapid Oral Abstract #5515). Puxi-Sam was recently granted Breakthrough Therapy Designation by the US Food and Drug Administration (FDA) in this setting.
PRIMAVERA: Safety and preliminary efficacy from the first-in-human Phase I PRIMAVERA trial of the protein arginine methyltransferase 5 (PRMT5) inhibitor AZD3470 as monotherapy in relapsed/refractory classic Hodgkin lymphoma (Oral Abstract #7003).
Phase I initial results for NT-175 T-cell receptor therapy in TP53 R175H-mutated unresectable, advanced and/or metastatic solid tumours including pancreatic adenocarcinoma (Oral Abstract #2506).
TROPION-Breast02: Additional efficacy endpoints from the TROPION-Breast02 Phase III trial of Datroway (datopotamab deruxtecan) as 1st-line treatment for patients with locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitors (Oral Abstract #1002).
DESTINY-Breast09: Exploratory analysis of treatment duration and clinical outcomes by complete response, partial response or stable/progressive disease in the DESTINY-Breast09 Phase III trial of Enhertu in combination with pertuzumab for the 1st-line treatment of patients with HER2-positive metastatic breast cancer (Rapid Oral Abstract #1021).
POTOMAC: Five-year overall survival and patient-reported outcomes from the Phase III POTOMAC trial of Imfinzi plus Bacillus Calmette-Guérin (BCG) induction and maintenance therapy in patients with high-risk non-muscle-invasive bladder cancer (Rapid Oral Abstract #4624).
Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "The data at ASCO (Free ASCO Whitepaper) for our innovative medicines and next-wave assets further our strategy to redefine patient outcomes by taking novel combinations into earlier stages of disease and advancing new modalities. New data for Enhertu, Datroway and camizestrant reinforce their transformational potential in breast cancer. We’re also excited to share first clinical data for our T-cell receptor therapy, NT-175, and our PRMT5 inhibitor, AZD3470, as well as updated data for our most advanced in-house antibody drug conjugate, Puxi-Sam, which was recently granted Breakthrough Therapy Designation by the FDA. Collectively, these datasets underscore the strength and depth of our oncology pipeline."

Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: "The EMERALD-3 data for Imfinzi and Imjudo in early liver cancer exemplify our successful strategy to move immunotherapy regimens into earlier stages of cancer where we can further improve outcomes for patients. With more than a dozen different indications approved across five cancer medicines in the last six months alone, we are reaching more patients with our growing portfolio, underscoring both the quality of our innovation and the strength of our business."

Gianluca Pirozzi, Head of Development, Regulatory and Safety, Alexion, said: "Results from the CARES Phase III clinical programme highlight the pioneering potential of anselamimab as a first-in-class, anti-fibril therapy for patients with kappa light chain amyloidosis. Its novel mechanism of action is designed to target and deplete amyloid deposits in affected organs, with potential to extend survival and reduce cardiovascular hospitalisations."

AstraZeneca is collaborating with Daiichi Sankyo to develop and commercialise Enhertu and Datroway.

Key AstraZeneca presentations during ASCO (Free ASCO Whitepaper) 20261

Lead Author

Abstract Title

Presentation details (CDT)

Antibody drug conjugates

Loi, S

Trastuzumab deruxtecan (T-DXd) + durvalumab (D) in patients (pts) with previously untreated HER2+ unresectable/metastatic breast cancer (mBC): Final analysis from DESTINY-Breast07.

Abstract #1012

Clinical Science Symposium

31 May 2026

09:18

Cescon, DW

First-line datopotamab deruxtecan (Dato-DXd) vs chemotherapy in patients with locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC) for who immunotherapy was not an option: Additional efficacy endpoints from the TROPION-Breast02 study.

Abstract #1002

Oral Abstract Session

2 June 2026

10:09

Mileshkin, LR

Updated safety and efficacy of puxitatug samrotecan (Puxi-Sam, AZD8205) in patients (pts) with endometrial cancer (EC) or ovarian cancer (OC): Phase 1/2a BLUESTAR study.

Abstract #5515

Rapid Oral Abstract Session

30 May 2026

09:00

Park, YH

A DESTINY-Breast09 analysis of treatment duration and clinical outcomes by best response to trastuzumab deruxtecan (T-DXd) + pertuzumab (P).

Abstract #1021

Rapid Oral Abstract Session

31 May 2026

12:42

Untch, M

Secondary safety analysis of trastuzumab deruxtecan (T-DXd) vs trastuzumab emtansine (T-DM1) in DESTINY-Breast05: Clinical and demographic risk factors of interstitial lung disease (ILD) and radiation pneumonitis (RP).

Abstract #516

Rapid Oral Abstract Session

1 June 2026

10:57

Shitara, K

Sonesitatug vedotin (Sone-Ve) monotherapy in patients (pts) with claudin 18.2–positive (CLDN18.2+) advanced or metastatic gastric or gastroesophageal junction (GEJ) cancers: Data from CLARITY-PanTumor01.

Abstract #4023

Poster Session

30 May 2026

09:00

Janjigian, Y

First-line (1L) trastuzumab deruxtecan (T-DXd)–based regimens in advanced HER2-expressing gastric cancer (GC), gastroesophageal junction adenocarcinoma (GEJA), or esophageal adenocarcinoma (EA): Safety results from DESTINY-Gastric03 (DG-03) Part 2 arms D and F, and Part 4.

Abstract #4022

Poster Session

30 May 2026

09:00

Zhang, Y

Trastuzumab deruxtecan (T-DXd) for pretreated patients in China with HER2 IHC 3+ solid tumors: DESTINY-PanTumor03 Part 1 primary analysis.

Abstract #3026

Poster Session

30 May 2026

13:30

Immuno-oncology

Abou-Alfa, GK

Efficacy and safety results from EMERALD-3: A phase 3, randomized study of tremelimumab plus durvalumab with or without lenvatinib combined with transarterial chemoembolization (TACE) in participants (pts) with unresectable embolization-eligible hepatocellular carcinoma (eeHCC).

Abstract #LBA4000

Oral Abstract Session

1 June 2026

09:45

Skoulidis, F

Tremelimumab (T) + durvalumab (D) + chemotherapy (CT) vs pembrolizumab (P) + CT in 1L non-squamous (NSQ) metastatic NSCLC (mNSCLC) with STK11, KEAP1, and/or KRAS mutations (mut): Interim analysis (IA) of the phase 2b TRITON study.

Abstract #8515

Rapid Oral Abstract Session

30 May 2026

13:45

Heymach, JV

Impact of neoadjuvant durvalumab (D) on tumor microenvironment (TME) features and their association with event-free survival (EFS) in patients with resectable NSCLC (R-NSCLC) from the phase 3 AEGEAN trial.

Abstract #8015

Rapid Oral Abstract Session

31 May 2026

17:30

De Santis, M

Durvalumab (D) in combination with BCG induction and maintenance (I + M) therapy for BCG-naive, high-risk non–muscle-invasive bladder cancer (NMIBC): 5-year overall survival (OS) analysis and patient-reported outcomes (PROs) from POTOMAC.

Abstract #4624

Rapid Oral Abstract Session

1 June 2026

08:12

IO Bispecifics

O’Sullivan, CC

Neoadjuvant rilvegostomig (R) + trastuzumab deruxtecan (T-DXd) in high-risk HER2-negative breast cancer: Results from the I-SPY 2.2 trial.

Abstract #LBA514

Rapid Oral Abstract Session

1 June 2026

10:45

Zhou, J

First-line rilvegostomig (R) + chemotherapy (CTx) in advanced biliary tract cancer (BTC): Updated analysis of GEMINI-Hepatobiliary substudy 2 cohort A.

Abstract #88

Poster Session

30 May 2026

09:00

Guo, Y

Volrustomig monotherapy for recurrent/metastatic HNSCC: Substudy 2 of the eVOLVE-02 phase 2 study.

Abstract #482

Poster Session

30 May 2026

13:30

Tumour drivers and resistance

Wang, Z

Osimertinib with/without chemotherapy in patients with persistent ctDNA EGFR mutant (EGFRm) NSCLC at 3 weeks after 1L osimertinib: A randomized phase II study (FLAME study).

Abstract #LBA101

Clinical Science Symposium

30 May 2026

08:40

Bidard, FC

First-line (1L) camizestrant (CAMI) for emergent ESR1 mutations (ESR1m) in advanced breast cancer (ABC): Final progression-free survival 2 (PFS2) from the phase III SERENA-6 trial.

Abstract #LBA1007

Oral Abstract Session

2 June 2026

11:57

Peng, Z

A phase 2 pivotal study of savolitinib in patients with MET-amplified gastric cancer or gastroesophageal junction adenocarcinomas.

Abstract #4011

Rapid Oral Abstract Session

1 June 2026

13:27

Cell Therapy

Surana, R

Initial phase 1 study results of NT-175 engineered T-cell therapy in TP53 R175H–mutated unresectable advanced solid tumors.

Abstract #2506

Oral Abstract Session

31 May 2026

10:00

Epigenetics

Derenzini, E

A phase 1 study of the PRMT5 inhibitor AZD3470 in patients with relapsed/refractory classic Hodgkin lymphoma (PRIMAVERA).

Abstract #7003

Oral Abstract Session

30 May 2026

16:00

Rare Disease

Wechalekar, AD

Phase 3 randomized trial to evaluate the impact of anselamimab on all-cause mortality in κ light chain amyloidosis.

Abstract #7501

Oral Abstract Session

29 May 2026

14:57

Chen, AP

Final analysis of KOMET (NCT04924608), a phase 3 study of selumetinib in adults with NF1-PN.

Abstract #3110

Poster Session

30 May 2026

13:30

More than 85 abstracts at ASCO (Free ASCO Whitepaper) 2026 will feature AstraZeneca medicines and pipeline molecules

(Press release, AstraZeneca, MAY 21, 2026, View Source [SID1234665951])

On May 21, 2026 Fulgent Genetics, Inc. (NASDAQ: FLGT) ("Fulgent" or the "Company"), a technology-based company with a well-established laboratory services business and a therapeutic development business, reported that its full abstract has been released on the ASCO (Free ASCO Whitepaper) 2026 website. The abstract will be presented within the Head and Neck Cancer Track of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Rapid Oral Abstract Session on June 1, 2026, from 4:30pm to 6:00pm (CDT) in Hall D1 of McCormick Place, Chicago.

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The abstract is entitled "FID-007 in combination with cetuximab in recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC), Abstract #6020". It presents interim data from the Company’s open-label, randomized Phase 2 study (NCT06332092). The study was designed to evaluate the efficacy of two different dosing regimens and to characterize the pharmacokinetics (PK) and safety and tolerability of FID-007 in combination with cetuximab in patients with disease progression after treatment with PD-1-based immune checkpoint inhibitor. As of the data cut-off date of December 20, 2025, FID-007 exhibited meaningful clinical activity and a favorable safety profile when combined with cetuximab in target patient population.

Key observations in the abstract include:

FID-007 combined with cetuximab demonstrated anticancer activity at both dose levels for the 1L–2L treatment of R/M HNSCC. Of the 42 patients evaluable for efficacy, the objective response rate (ORR) was 60% (58% in Arm A, 61% in Arm B), and the median progression-free survival (mPFS) was 7.2 mo [6.7 mo in Arm A (95% CI: 2.0-12.8), and 7.2 mo in Arm B (95% CI: 4.0-NR)]. The median duration of response (DoR) was 7.4 mo (7.4 mo in Arm A, NR in Arm B) with 56% (14/25) of responders continuing to respond at the time of data cut-off. The overall survival data (OS) are immature at present.
FID-007 exhibited a favorable safety and tolerability profile consisting mostly of grade 1-2 treatment-related adverse events (TRAEs). Grade 3-4 TRAEs occurring in ≥ 2 patients included neutropenia (3 in Arm A, 5 in Arm B), anemia (2 in Arm A, 4 in Arm B), leukopenia (3 in Arm B), acneiform dermatitis (2 in Arm A), maculo-papular rash and other rash (2 in Arm B). There was 1 Grade 5 TRAE (pneumonia in Arm B).
The full abstract is now available on the ASCO (Free ASCO Whitepaper) website, as well as on Fulgent’s investor relations website.

The final presentation slides with updated data will be available on Fulgent’s investor relations website at the start of the session on June 1, 2026.

Dr. Ray Yin, Co-Founder and President of Fulgent Pharma, said, "Based on available estimates, there are approximately 73,000 new head and neck Squamous Cell Carcinoma (HNSCC) cases in the U.S. and 930,000 worldwide each year, with 50% to 60% progressing to the recurrent or metastatic stage. We are encouraged by the clinical progress achieved so far and believe in the potential of FID-007 to serve as a meaningful treatment for R/M HNSCC patients, particularly given that the current standard of care offers a historical objective response rate (ORR) of just 5.8% to 19.1% and a progression-free survival (PFS) of only 2.3 to 3.7 months."

(Press release, Fulgent Genetics, MAY 21, 2026, View Source [SID1234665967])

On May 21, 2026 Autolus Therapeutics plc (Nasdaq: AUTL), a commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies and candidates, reported the online publication of an abstract submitted to the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to be held May 29 – June 2, 2026, in Chicago, Illinois.

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"Data to be presented at the upcoming ASCO (Free ASCO Whitepaper) Annual Meeting provides insight into the use of obe-cel in patients with B-ALL and extramedullary disease (EMD), which is typically associated with shorter median and long-term survival compared to marrow-only relapse. With an overall response rate of 59% and a median duration of response (mDOR) of 42.6 months for patients with EMD, obe-cel may be considered as a potential treatment option for this difficult to treat population of patients," said Matthias Will, MD, Autolus Chief Development Officer.

Abstract 6517
Title: The effect of obecabtagene autoleucel (obe-cel) on adult patients (pts) with relapsed/refractory B-cell acute lymphoblastic leukemia (R/R B-ALL) and extramedullary disease (EMD).
Session Type and Track: Rapid Oral Abstract: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant.
Session Date and Time: May 30, 2026; 1:15 – 2:45PM CDT
Session Room: E450a
Abstract Number: 6517
Presentation time: 2:27 – 2:33pm CDT
Presenting Author: Jae Park, MD, Director, Adult ALL Program | Acting Chief, Cellular Therapeutics, Memorial Sloan Kettering Cancer Center, New York, NY, USA

Summary: A post-hoc analysis of the Phase Ib/II FELIX study (NCT04404660) was conducted, evaluating the efficacy and safety of obe-cel in patients with relapsed or refractory (r/r) B-ALL, by EMD status at lymphodepletion (LD). Following LD, adults with r/r B-ALL received obe-cel using a tumor burden-guided dosing strategy to minimize toxicity. Obe-cel treatment demonstrated favorable response and safety outcomes in patients with and without EMD in the FELIX trial. Of 127 obe-cel infused patients, 27 (21%) had EMD at LD. Among responders, duration of response in patients with EMD was 42.6 months, and the overall remission rate was 59%. Overall, these findings suggest a positive benefit–risk profile for obe-cel, including for patients with adverse risk features, specifically EMD at LD.

(Press release, Autolus, MAY 21, 2026, View Source [SID1234665983])

On May 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 positive results from its Phase 2 trial of silevertinib in frontline (1L) non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) non-classical mutations (NCMs). These data will be presented by Julia Rotow, M.D., Clinical Director, Lowe Center for Thoracic Oncology at the Dana-Farber Cancer Institute, at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on Saturday, May 30, 2026, 1:15 PM-2:45 PM CDT.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"Silevertinib continues to demonstrate potential to become a practice changing frontline therapy for NSCLC patients with EGFR-NCMs, delivering robust preliminary mPFS that far exceeds historical data for currently available therapies" said Sergey Yurasov, M.D., Ph.D., Chief Medical Officer of Black Diamond Therapeutics. "Importantly, silevertinib prevented the development of de novo brain metastases in this patient population, where progression via CNS metastases frequently occurs. We look forward to meeting with the FDA later this year to discuss our pivotal development plan."

"Patients with EGFR non-classical mutations represent a meaningful and underserved subset of NSCLC, with historically poor progression-free survival on available frontline TKIs," added Dr. Rotow. "The activity we are seeing with silevertinib across the full NCM spectrum, combined with its CNS activity, is highly encouraging, and I look forward to sharing these data with the oncology community at ASCO (Free ASCO Whitepaper) next week."

Silevertinib 1L NSCLC Phase 2 Results Summary

Results as of an April 11, 2026 data cutoff date include:

43 patients with 1L NSCLC were enrolled at a 200 mg once daily dose of silevertinib
Patients presented with a broad spectrum of EGFR-NCMs, including compound and P-Loop and C-Helix Compressing (PACC) mutations
19 patients with brain metastases, 7 of whom had measurable central nervous system (CNS) target lesions
11.2 months median follow-up

Durability
Preliminary median Progression-free Survival (mPFS) is 15.2 months (95% CI: 10.8; NE)
Median duration of response (DOR) had not been reached (95%CI: 7.0, NE)
23 of 43 patients (53%) remain on therapy, with longest at 23.5 months

CNS Activity
No patients developed de novo brain metastases
Previously disclosed CNS Objective Response Rate (ORR by RANO-BM) remained at 86%

ORR and DCR
Previously disclosed Objective Response Rate (ORR by RECIST 1.1) and Disease Control Rate (DCR) remained at 60% and 91%, respectively
Variant allele frequency (VAF) reduction observed in all evaluable patients across 25 unique EGFR-NCMs, including PACC

Safety
No new safety signals were observed
The rate of TRAEs > Grade 3 was reduced to 28% following dose reduction
Patients maintained or deepened clinical responses after dose reduction
Safety and efficacy data support 150 mg QD for pivotal development

ASCO Abstract: 8519
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
Presenter: Julia Rotow, M.D., Clinical Director, Lowe Center for Thoracic Oncology at Dana-Farber Cancer Institute
Date and Time: May 30, 2026, 1:15 PM-2:45 PM CDT (slides will be available at the time of the presentation on the Black Diamond website)

Company Webcast Information
Black Diamond will hold a webcast for investors on Thursday, May 21, 2026 at 5:30 p.m. EDT. The webcast can be accessed under "Events and Presentations" on the Investors section of the Black Diamond website at www.blackdiamondtherapeutics.com.

About Silevertinib

Silevertinib is an investigational 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 is also designed to potently inhibit 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 addition to the ongoing Phase 2 trial of silevertinib in patients with EGFRm NSCLC, the Company also initiated a randomized Phase 2 trial of silevertinib in patients with newly diagnosed EGFRvIII-positive GBM (NCT07326566) in May 2026.

(Press release, Black Diamond Therapeutics, MAY 21, 2026, View Source [SID1234665920])

On May 21, 2026 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, reported preliminary clinical data from the Phase 1 study of OP-3136, a potent lysine acetyltransferase 6 (KAT6) inhibitor. The data will be presented in a poster presentation on May 30, 2026 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place in Chicago, Illinois. Olema will also present a trial-in-progress poster for the Phase 3 OPERA-02 trial of palazestrant in combination with ribociclib in frontline estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) metastatic breast cancer.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"We are pleased to share the initial Phase 1 data for OP-3136, which demonstrated acceptable tolerability and promising anti-tumor activity as a monotherapy across multiple dose levels in various advanced solid tumor types," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "The decreases in tumor size observed in over two-thirds of evaluable patients and evidence of on-target engagement reinforce our confidence in OP-3136 as a potential best-in-class KAT6 inhibitor and a potentially differentiated option for difficult-to-treat cancers. We look forward to progressing OP-3136 in development, particularly in combination with palazestrant in metastatic breast cancer."

The Phase 1 study evaluates dose escalation followed by dose expansion of OP-3136 in patients with ER+/HER2- advanced breast cancer (ABC), metastatic castration-resistant prostate cancer (mCRPC), and metastatic non-small cell lung cancer (mNSCLC). In Part 1A, OP-3136 monotherapy was administered orally once daily in 28-day cycles across dose levels from 2 mg to 45 mg. As of the March 2, 2026 data cut-off, 32 heavily pretreated patients who became resistant or intolerant to standard of care treatments were enrolled in this cohort.

Key Findings
Safety and Tolerability

OP-3136 monotherapy was well-tolerated with no dose-limiting toxicities observed across the evaluated daily dose range up to 45 mg per day orally.
Most treatment-related adverse events (TRAEs) were grade 1 or 2; no grade 4 or 5 TRAEs were observed. TRAEs were manageable with dose modifications; no treatment discontinuations occurred due to TRAEs.
The most common TRAEs were dysgeusia (81% any grade; 56% grade 1, 25% grade 2), anemia (38% any grade; 6% grade 3), and neutropenia (34% any grade; 28% grade 3).

Efficacy and Target Engagement

Among 19 response-evaluable patients across dose levels and tumor types, tumor shrinkage was observed in 13 patients; partial responses (PR) were observed in 3 patients with measurable disease, with 2 confirmed PRs and 1 unconfirmed PR.
The longest duration of treatment is 62 weeks.
11 patients remain on treatment, including 9 with ABC and 2 with mCRPC.
Across all doses tested, OP-3136 demonstrated rapid, sustained, and significant reduction in levels of lysine 23 of histone H3, a direct target of KAT6, consistent with on-target KAT6 inhibition.

Pharmacokinetics

OP-3136 exhibited predictable, dose-proportional plasma exposure across all doses tested.
At doses of 6 mg and above, steady-state concentrations exceeded efficacy targets based on preclinical models.

"These initial results from the Phase 1 study of OP-3136, including confirmed and durable responses and a manageable safety profile in a heavily pretreated population, underscore the potential of KAT6 inhibition as a therapeutic strategy in different solid tumor types," said Amita Patnaik, MD, FRCPC, Principal Investigator, Co-Founder, and Co-Director of Clinical Research at the START Center for Cancer Research. "Supported by evidence of target engagement and predictable pharmacokinetics across all doses evaluated to date, I am excited to further evaluate this novel therapy, both as a monotherapy and in combination with multiple agents, as Phase 1 development continues."

OP-3136 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: preliminary results
Abstract Number: 3088
Poster Number: 225
Date/Time: May 30, 2026 from 1:30pm-4:30pm CT / 2:30pm-5:30pm ET

OPERA-02 Trial-in-Progress Poster Presentation Details
Olema will also present a trial-in-progress poster for the Phase 3 OPERA-02 trial of palazestrant in combination with ribociclib in frontline ER+/HER2- metastatic breast cancer.

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

Copies of these posters will be available on the Publications page of Olema’s website in alignment with the ASCO (Free ASCO Whitepaper) embargo. Additional information, including abstracts, is available on the ASCO (Free ASCO Whitepaper) Annual Meeting website.

(Press release, Olema Oncology, MAY 21, 2026, View Source [SID1234665936])