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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"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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"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])

On May 21, 2026 Agendia, Inc., a leader in precision oncology for breast cancer, reported new data to be presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 29 – June 2 in Chicago. The company will present two posters highlighting how MammaPrint (MP) + BluePrint (BP) provide biological insights into treatment response and help further refine therapeutic decision-making for patients with early-stage breast cancer (EBC).

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Poster #46 | June 1, 1:30 p.m. – 4:30 p.m. CDT | Presenter: Steven Isakoff

Association of the 70-gene assay and homologous recombination deficiency in patients with High Risk 2 breast cancers

This real-world analysis of 1,298 patients from the FLEX study evaluated whether MP + BP classifications are associated with homologous recombination deficiency (HRD) in hormone receptor positive, HER2-negative (HR+HER2-) EBC. A 228-gene HRD signature and a refined 26-gene panel were used to assess HRD-related biology indicative of impaired DNA repair.

Both signatures showed that MP High Risk 2 (H2) tumors demonstrated significantly higher HRD scores than High Risk 1 (H1) tumors (both p<0.001).
Among Luminal tumors, Luminal H2 tumors had significantly higher HRD scores than Luminal H1 tumors across both HRD signatures (both p<0.001).
Basal tumors demonstrated higher HRD scores than Luminal tumors within both H1 and H2 groups (all p≤0.002), with Basal H2 tumors showing the highest overall HRD levels.
"These findings provide a biological rationale for the anthracycline chemotherapy benefit observed in patients with MammaPrint High Risk 2 tumors," said Steven Isakoff, M.D., Ph.D., Medical Oncologist and Clinical Director, Breast Oncology Program, Mass General Brigham Cancer Institute. "Following the recent NCCN Guidelines update recognizing MammaPrint as the only genomic test to personalize the use of anthracycline-based regimens in HR+HER2- early-stage breast cancer, the data further validate the assay’s ability to stratify risk and guide treatment selection."

Poster #106 | June 1, 1:30 p.m. – 4:30 p.m. CDT | Presenter: David Page

Integration of molecular subtyping and immune profiling to predict pathologic complete response in HER2+ breast cancer treated with neoadjuvant dual HER2 therapy

This study evaluates whether combining BP molecular subtyping with the ImPrint immune signature could accurately predict outcomes (pathologic complete response [pCR]) in HER2-positive (HER2+) EBC treated with neoadjuvant dual HER2-targeted therapy. pCR rates were assessed in a cohort of 252 patients, following treatment with neoadjuvant chemotherapy in combination with trastuzumab and pertuzumab.

In the HR+HER2+ subgroup, 52% of tumors were further classified by BP as non-HER2 subtypes (Luminal A 6%, Luminal B 44%, Basal 2%), highlighting the genomic diversity within clinically HER2+ disease.
The highest pCR rates were observed in tumors classified as BP-HER2/ImPrint+, indicating that patients whose tumors were genomically HER2-type and immune-active derived the greatest benefit from neoadjuvant therapy.
In multivariate analysis, BP subtype and ImPrint status independently predicted pCR in HR+HER2+ disease, after controlling for nodal status and tumor size. The integration of molecular subtyping by BP and immune profiling by ImPrint maximized prediction of pCR, particularly in the HR+HER2+ subgroup.
"These findings demonstrate how integrating molecular subtyping with immune profiling may improve our ability to predict response to neoadjuvant therapy in HER2-positive early-stage breast cancer and may be hypothesis-generating for chemotherapy de-escalation studies," said William Audeh, M.D., Chief Medical Officer of Agendia. "Both the HRD and HER2+ studies highlight the utility of MammaPrint and BluePrint and emerging signatures for identifying clinically relevant breast cancer biology. Drawing on insights from the FLEX Study, which captures real-world treatment patterns as they evolve, we can address challenging clinical questions in a timely and relevant manner."

ImPrint was developed to be used in the clinic to predict the likelihood of patients responding to immunotherapies by looking at the biology of the patient’s tumor. Agendia currently holds a U.S. Food and Drug Administration Investigational Device Exempt status for the ImPrint signature, allowing for its use in the I-SPY2 trial and for other ongoing research with collaborators.

(Press release, Agendia, MAY 21, 2026, View Source [SID1234665968])