Update on the Phase 3 STAR-121 Study of Anti-TIGIT Antibody Domvanalimab and Anti-PD-1 Antibody Zimberelimab in Non-Small Cell Lung Cancer

On April 20, 2026 Taiho Pharmaceutical Co., Ltd. ("Taiho") reported the discontinuation of the Phase 3 STAR-121 study due to futility. STAR-121 study, which is being conducted in collaboration with Arcus Biosciences, Inc. ("Arcus") and Gilead Sciences, Inc. ("Gilead"), evaluated the anti-TIGIT antibody domvanalimab (development code: AB154) plus anti-PD-1 antibody zimberelimab (development code: AB122) and chemotherapy versus pembrolizumab plus chemotherapy as a first-line treatment for metastatic non-small cell lung cancer.

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The decision is based on the recommendation from the Independent Data Monitoring Committee ("IDMC"), following its review of data from a pre-planned futility analysis. Safety was not assessed at this futility analysis; however, no new safety issues have been identified during regular reviews by the IDMC.

Communication with investigators is being conducted to determine appropriate next steps for patients in the study.

Domvanalimab and zimberelimab are investigational molecules, and this combination therapy has not received approval from any regulatory authority for any use globally, and their safety and efficacy have not been established.

About Non-Small Cell Lung Cancer
Lung cancer remains the most diagnosed cancer and is the leading cause of cancer‑related death, with approximately 2.5 million incident cases and 1.8 million deaths reported annually worldwide1. Lung cancer presents as small cell lung cancer (SCLC) and non–small cell lung cancer ("NSCLC"), of which the latter represents approximately 85% of all lung cancer diagnoses2. While distribution of NSCLC histology can vary depending on factors such as gender or geographic regions, adenocarcinoma (45%) and squamous (25%) subtypes account for the largest share of cases of NSCLC in the United States3.

About the STAR-121 Study
STAR-121 is a randomized, open-label, global Phase 3 trial consisting of 1) zimberelimab and domvanalimabplus chemotherapy arm, 2) pembrolizumab plus chemotherapy arm, and 3) zimberelimab plus chemotherapy arm as first-line treatment in patients with metastatic NSCLC with no Epidermal Growth Factor Receptor (EGFR), Anaplastic Lymphoma Kinase (ALK) mutations or other actionable genomic alteration.

The primary endpoint of the study is overall survival (OS) in participants with positive PD-L1 expression (≥ 1% tumor cells) and in all randomized participants.

STAR-121 Study: A Randomized, Open-Label, Phase 3 Study to Evaluate Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy for the First-Line Treatment of Patients With Metastatic Non-Small Cell Lung Cancer With No Epidermal Growth Factor Receptor or Anaplastic Lymphoma Kinase Genomic Tumor Aberrations

About Domvanalimab
Domvanalimab is an Fc-silent investigational monoclonal antibody which binds the T-cell immunoreceptor with Ig and ITIM domains (TIGIT), a checkpoint receptor on immune cells that acts as a brake on the anticancer immune response. By binding to TIGIT with Fc-silent properties, domvanalimab is believed to work by freeing up immune-activating pathways and activating immune cells to attack and kill cancer cells without depleting the peripheral regulatory T cells important in avoiding immune-related toxicity.

Combined inhibition of both TIGIT and programmed cell death protein-1 (PD-1) is believed to enhance immune cell activation, as these checkpoint receptors play distinct, complementary roles in anti-tumor activity.

About Zimberelimab
Zimberelimab is an anti-programmed cell death protein-1 (PD-1) monoclonal antibody that binds PD-1, with the goal of restoring the antitumor activity of T cells.

Zimberelimab is being evaluated globally as a foundational anti-PD-1 treatment option in multiple ongoing clinical studies.

About the Taiho and Arcus Agreement
Based on the option and license agreement that Taiho and Arcus entered into in 2017, Taiho has obtained exclusive development and commercialization rights to a total of five Arcus programs in Japan and certain other territories in Asia (excluding mainland China): (1) etrumadenant, a dual A2a/b adenosine receptor antagonist program in 2018; (2) zimberelimab, the anti-PD-1 program in 2019; (3) domvanalimab, the anti-TIGIT program in 2021; (4) quemliclustat, CD73 inhibitor program in 2024, and (5) casdatifan, HIF-2α inhibitor in 2025.

(Press release, Taiho, APR 20, 2026, View Source [SID1234664555])

Regeneron Announces Investor Conference Presentations

On April 20, 2026 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported will webcast management participation as follows:

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• BofA Securities Health Care Conference 2026 at 10:00 a.m. PT (1:00 p.m. ET) on Tuesday, May 12, 2026

• Goldman Sachs 47th Annual Global Healthcare Conference at 2:00 p.m. ET on Monday, June 8, 2026

The sessions may be accessed from the "Investors & Media" page of Regeneron’s website at View Source Replays and transcripts of the webcasts will be archived on the Company’s website for at least 30 days.

(Press release, Regeneron, APR 20, 2026, View Source [SID1234664552])

Prelude Therapeutics Announces Pricing of $90.0 Million Underwritten Offering

On April 20, 2026 Prelude Therapeutics Incorporated (Nasdaq: PRLD) ("Prelude" or the "Company"), a clinical-stage precision oncology company, reported the pricing of its underwritten offering of 18,018,014 shares of its voting common stock (the "Common Stock") at a price of $4.44 per share, and, in lieu of Common Stock to investors who so chose, pre-funded warrants to purchase up to 2,252,252 shares of its Common Stock at a price of $4.4399 per pre-funded warrant, which represents the per share offering price for the Common Stock less the $0.0001 per share exercise price for each such pre-funded warrant. Before deducting the underwriting discounts and commissions and estimated offering expenses, the total gross proceeds to Prelude are approximately $90.0 million. The offering is expected to close on or about April 21, 2026, subject to the satisfaction of customary closing conditions.

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The offering was led by new investor RA Capital Management with participation from Soleus Capital, as well as other new and existing healthcare dedicated investors.

Goldman Sachs & Co. LLC, Evercore ISI and Citizens Capital Markets are acting as the joint book-running managers for the offering.

The Company intends to use the net proceeds from the offering primarily for general corporate purposes, which may include funding research, preclinical and clinical development of its product candidates, increasing its working capital and capital expenditures.

A registration statement on Form S-3 relating to these securities was filed with the Securities and Exchange Commission ("SEC") on May 30, 2024, and was declared effective by the SEC on June 10, 2024. A prospectus supplement and accompanying prospectus relating to this offering will be filed with the SEC. These documents will be available on the SEC’s website at View Source You can also obtain the prospectus supplement and accompanying prospectus by contacting Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, by telephone at (866) 471-2526, or by email at [email protected]; or Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, by telephone at (888) 474-0200, or by email at [email protected]; or Citizens JMP Securities, LLC, 600 Montgomery Street, Suite 1100, San Francisco, CA 94111, by telephone at (415) 835-8985, or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any offer or sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

(Press release, Prelude Therapeutics, APR 20, 2026, View Source [SID1234664551])

Prelude Therapeutics Presents Preclinical Data from Development Candidate, PRT13722, a First-in-Class, Orally Bioavailable, Potent and Highly Selective KAT6A Degrader at American Association for Cancer Research (AACR) Annual Meeting 2026

On April 20, 2026 Prelude Therapeutics Incorporated (Nasdaq: PRLD), a precision oncology company, reported the presentation of new preclinical data from its lead development candidate, PRT13722. PRT13722 is being developed for the treatment of hormone receptor positive (HR+)/human epidermal growth factor receptor 2 (HER2-) breast cancer (BC). Based on preclinical data, we believe PRT13722 is a highly differentiated, first-in-class, orally bioavailable, potent and highly-selective KAT6A degrader.

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"These preclinical data further strengthen our hypothesis that developing a highly selective degrader specifically targeting KAT6A has the potential for further improvements of efficacy and importantly an improved hematological safety profile. We believe the efficacy and safety profile of PRT13722 will, in turn, enable meaningful combination approaches to existing standards of care," stated Peggy Scherle, Ph.D., Chief Scientific Officer of Prelude. "We remain on track to file an Investigational New Drug (IND) application for PRT13722 in the middle of this year and, pending clearance, enter the clinic in the second half of 2026."

"There remains a significant unmet need for new treatment options to further improve the standard of care in breast cancer," stated Edith A. Perez, M.D., Professor Emeritus at Mayo Clinic and strategic clinical advisor to Prelude. "New agents that show potential for relevant clinical efficacy and improved tolerability could enable alternative treatment strategies and novel combinations across multiple lines of therapy. It is important to follow the science as these promising new agents prepare to enter the clinic, including PRT13722."

Details on the poster presentation are as follows:

Title: First-in-Class potent and selective oral KAT6A degrader development candidate, PRT13722, drives complete tumor regressions as a monotherapy with an improved preclinical hematological safety profile.

Abstract Control Number: 7335
Session Title: Proximity-Induced Drug Discovery 2
Session Start Time: 4/21/2026 2:00 PM PT
Location: Poster Section 15
Poster Board Number: 20
Presentation Number: 5793

Summary:

PRT13722 is a highly differentiated, first-in-class, orally bioavailable, potent and highly selective KAT6A degrader development candidate.
PRT13722, by degrading KAT6A, drives more complete disruption of KAT6A regulatory pathways than dual KAT6A/B inhibitors, resulting in more robust depth and breadth of preclinical efficacy in HR+/HER2- breast cancer.
PRT13722 drives durable complete tumor regressions in HR+/HER2- xenograft models (both endocrine therapy (ET) sensitive and experienced) at well-tolerated doses, as a monotherapy.
PRT13722 is synergistic with ET, CDK4/6 inhibitors, and PI3Kα inhibitors while maintaining monotherapy and combination activity across HR+ BC models, including estrogen receptor 1 mutated and acquired therapy-resistant cancer cells.
PRT13722 has an improved preclinical hematological safety profile compared to prifetrastat, which may enable combinations with standard of care agents in HR+ BC.
PRT13722 is on track for IND filing in mid-2026.
Link to Poster Presentation: Publications – Prelude Therapeutics (preludetx.com)

Highly selective KAT6A oral degrader program
KAT6 is an emerging and recently validated target in the treatment of ER+ breast cancer. Prelude discovered and is developing first-in-class, highly potent, highly selective and orally bioavailable KAT6A selective degraders. PRT13722 remains on track for an IND filing in mid-2026 and subject to clearance, with Phase 1 study initiation planned in the 2nd half of 2026. Prelude believes that selectively degrading KAT6A has the potential for improved efficacy, tolerability and combinability with other agents relative to non-selective inhibitors of KAT6A/B.

The Company presented initial preclinical data supporting this hypothesis at the AACR (Free AACR Whitepaper) Annual Meeting 2025. The presentation can be found at Publications – Prelude Therapeutics.

Additional AACR (Free AACR Whitepaper) Presentation
On April 18, 2026, Prelude’s Sr. Director of Biology and Pharmacology, Koichi Ito, Ph.D. provided a lecture during an educational session entitled: ED08 – Chemistry to the Clinic Part 1 of 4: Next-Level Conjugates: Transforming Targeted Therapies. The title of the presentation is: "Beyond Conventional Payloads: Unlocking New Therapeutic Landscapes with Targeted Protein Degrader-Antibody Conjugates (DACs)"

(Press release, Prelude Therapeutics, APR 20, 2026, View Source [SID1234664550])

PharmaMar’s Zepzelca® (lurbinectedin) and atezolizumab (Tecentriq®) has obtained another three approvals as first-line maintenance therapy for small cell lung cancer

On April 20, 2026 PharmaMar (MSE:PHM) reported that the Australian Therapeutic Goods Administration (TGA) and the Health Sciences Authority (HSA) in Singapore have granted approval for Zepzelca (lurbinectedin) in combination with atezolizumab (Tecentriq) as a first line maintenance treatment for adults with extensive-stage small cell lung cancer (ES-SCLC), whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide.

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The approvals are based on the results from the Phase 3 IMforte[i]trial.

PharmaMar’s partner in Australia and Singapore, Specialised Therapeutics Asia Pte, Ltd (STA), will market and commercialize the product.

These approvals were obtained under the Orbis Project, an initiative of the U.S. Food and Drug Administration’s (FDA) Oncology Center of Excellence, designed to provide a framework for concurrent submission and review of oncology products among international partners. As of today, this treatment is approved in a total of 13 countries: the US, Switzerland, the United Arab Emirates, Oman, Uruguay, Peru, Paraguay, Ecuador, Israel, Taiwan, Australia, Singapore and Dominican Republic.

PharmaMar also received a recommendation for approval from the European Medicines Agency in March. The European Commission will now decide on the marketing authorization in accordance with the established procedure.

(Press release, PharmaMar, APR 20, 2026, View Source [SID1234664549])