On October 1, 2025 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported the presentation of clinical research across its oncology portfolio and pipeline during the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025, which is taking place in Berlin, Germany from October 17 to 21 (Press release, Eisai, OCT 1, 2025, View Source [SID1234656400]).

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Among the notable presentations is data from the Phase 3 Study 309/KEYNOTE-775 trial, which evaluated lenvatinib (LENVIMA), the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, plus pembrolizumab (KEYTRUDA*1), MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy versus treatment of physician’s choice for patients with advanced endometrial carcinoma. The presentation will feature 5-year overall survival data providing deeper insights into long-term treatment for patients affected by this disease (NCT03517449; Abstract #1119P).

"The 5-year overall survival follow-up from Study 309/KEYNOTE-775 being presented at ESMO (Free ESMO Whitepaper) highlights the consistency of the study data over time, supporting the established role of lenvatinib plus pembrolizumab in the treatment landscape of endometrial cancer and underscoring Eisai’s commitment to generating the long-term evidence that patients, families, and healthcare providers rely on to make informed treatment decisions," said Dr. Corina Dutcus, Senior Vice President, Oncology Global Clinical Development Lead at Eisai Inc. "Our research in endometrial cancer, alongside our data in renal cell carcinoma and innovative pipeline approaches, reflects our dedication to our human health care concept to address unmet medical needs and advance treatment options for people living with cancer."

Further endometrial cancer research includes additional 1-year follow-up results from the Phase 3 LEAP001 study in first-line advanced or recurrent endometrial carcinoma (NCT03884101; Abstract #1114P), as well as a combined analysis examining post-(neo)adjuvant therapy outcomes from both the Study 309/KEYNOTE-775 and LEAP-001 studies (Abstract #1124P). In renal cell carcinoma (RCC), final analysis data from the CLEAR study comparing lenvatinib plus pembrolizumab versus sunitinib in patients with advanced RCC with or without bone metastases will be presented (NCT02811861; Abstract #2603P).

Research from Eisai’s pipeline includes clinical and biomarker results from Study 102 evaluating E7386, a CREB-binding protein (CBP)/β-catenin interaction inhibitor, in combination with lenvatinib in patients with advanced or recurrent endometrial carcinoma (NCT04008797; Abstract #1153P).

This release discusses investigational compounds and investigational uses for FDA-approved products. It is not intended to convey conclusions about efficacy and safety. There is no guarantee that any investigational compounds or investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval.

The full list of Eisai presentations is included below. Regular abstracts will be made available via the ESMO (Free ESMO Whitepaper) website on 12:05 AM Central European Summer Time (CEST) on Monday, October 13, 2025. Latebreaking abstracts accepted for presentation at ESMO (Free ESMO Whitepaper) as a Proffered Paper or Mini Oral will be published on the ESMO (Free ESMO Whitepaper) website at 12:05 AM CEST on the day of presentation. Posters will be on display from 9:00 AM – 5:00 PM CEST on the day of their poster session.

Cancer Type Study/Compound Presentation Title Presentation Type & Details
Lenvatinib Plus Pembrolizumab
Gynecologic Cancer
Study 309/
KEYNOTE-775
Lenvatinib plus pembrolizumab (L+P) vs
treatment of physician’s choice (TPC) for
advanced endometrial cancer (EC): 5-Year
outcomes from Study 309/KEYNOTE-775
Poster Session
Presentation #1119P
October 18, 2025
LEAP-001
First-line lenvatinib + pembrolizumab (L+P) vs
chemotherapy (CT) for advanced or recurrent
endometrial cancer (EC): additional 1-year
follow-up results from ENGOT-en9/LEAP-001
Poster Session
Presentation #1114P
October 18, 2025
Study 309/
KEYNOTE-775 and
LEAP-001
Lenvatinib + pembrolizumab (L+P) in participants
(Pts) with advanced or recurrent endometrial
cancer (aEC): Study 309/KEYNOTE-775 and
ENGOT-en9/LEAP-001 post-(neo)adjuvant
therapy outcomes
Poster Session
Presentation #1124P
October 18, 2025
Gastrointestinal Cancer LEAP-014
Lenvatinib plus pembrolizumab and
chemotherapy versus pembrolizumab and
chemotherapy in untreated metastatic
esophageal squamous cell carcinoma: the
randomized Phase 3 LEAP-014 Study
Proffered Paper Session
Presentation #LBA79
October 17, 2025
2:40-2:50 PM
Genitourinary Cancer CLEAR
Final analysis of lenvatinib + pembrolizumab
(L+P) vs sunitinib (S) in patients with advanced
renal cell carcinoma (aRCC) with or without bone
metastases in CLEAR
Poster Session
Presentation #2603P
October 18, 2025
Pipeline
Gynecologic Cancer E7386*2
Clinical and biomarker results from E7386 study
102: global dose-expansion cohort of E7386 +
lenvatinib (LEN) in patients (pts) with
advanced/recurrent endometrial cancer (aEC)
that progressed on platinum-based
chemotherapy (PBC) and an anti-PD-(L)1
immunotherapy (IO)
Poster Session
Presentation #1153P
October 18, 2025
The following presentations represent studies including lenvatinib treatment sponsored by MSD.
Cancer Type Study/Compound Presentation Title Presentation Type & Details
Genitourinary Cancer
LITESPARK-010
Belzutifan plus lenvatinib for Chinese participants
(pts) with previously treated advanced clear cell
renal cell carcinoma (ccRCC): updated results of
cohort 1 of the LITESPARK-010 study
Poster Session
Presentation #2615P
October 18, 2025
KEYMAKER-U03A
First-line pembrolizumab-based regimens for
advanced clear cell renal cell carcinoma:
KEYMAKER-U03 substudy 03A
Proffered Paper Session
Presentation #LBA96
October 18, 2025
8:30-8:40 AM
Melanoma KEYMAKER-U02B
First-line pembrolizumab alone or with
investigational agents for advanced melanoma:
updated results from the phase 1/2 KEYMAKERU02 substudy 02B
Poster Session
Presentation #1621P
October 20, 2025

In March 2018, Eisai and MSD, through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvatinib, both as monotherapy and in combination with the anti-PD-1 therapy from MSD, pembrolizumab. Eisai and MSD are studying the lenvatinib plus pembrolizumab combination through the LEAP (LEnvatinib And Pembrolizumab) clinical program. Lenvatinib plus pembrolizumab is approved in the U.S., the EU, Japan and other countries for the treatment of advanced RCC and certain types of advanced endometrial carcinoma. Lenvatinib is approved as KISPLYX for advanced RCC in the EU.

On October 1, 2025 Bolt Biotherapeutics (Nasdaq: BOLT), a clinical-stage biopharmaceutical company developing novel immunotherapies for the treatment of cancer, reported an update on the ongoing Phase 1 dose escalation study of BDC-4182, a next-generation Boltbody ISAC clinical candidate targeting claudin 18.2, a clinically validated target in oncology (Press release, Bolt Biotherapeutics, OCT 1, 2025, View Source [SID1234656398]). A strong immune response was observed at the initial dose levels and the Company is in the process of modifying the clinical trial protocol to allow for step-up dosing, which has been successfully used commercially for T-cell engagers. BDC-4182 preclinical data supports this approach.

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As a result of the update to the clinical trial protocol for BDC-4182, Bolt now expects to report initial clinical data in the third quarter of 2026. To conserve capital and maintain long-term shareholder value, the Company is implementing a workforce reduction of approximately 50%, extending its cash runway into 2027.

"I want to sincerely thank all of our colleagues impacted by this decision. Their commitment and valuable contributions have been essential in developing our novel BoltbodyTM ISAC technology and these potential new treatment options for patients with cancer," said Willie Quinn, President and Chief Executive Officer. "Amid challenging market conditions, our strategic imperative is the clinical advancement of BDC-4182 and the support of our ISAC collaborations to increase shareholder value. We look forward continuing our mission and to providing updates on BDC-4182 later next year."

On October 1, 2025 KaliVir Immunotherapeutics, Inc., a clinical-stage biotechnology company developing cutting-edge, multi-mechanistic oncolytic immunotherapy programs, reported the successful completion of the first cohort in the intravenous (IV) infusion arm of its STEALTH-001 (NCT06444815) clinical study, a Phase 1/1b clinical trial of VET3-TGI for patients with incurable, advanced solid tumors (Press release, KaliVir Immunotherapeutics, OCT 1, 2025, View Source [SID1234656389]).

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Patients received VET3-TGI, the Company’s lead oncolytic immunotherapy candidate, which is designed to selectively kill tumor cells and remodel the tumor microenvironment by delivering a potent immuno-stimulatory transgene payload composed of interleukin-12 (IL-12) and a TGFbeta inhibitor.

"The dosing of patients in the IV arm marks a significant advancement for the STEALTH-001 study and the broader field of systemic oncolytic viral immunotherapy," said Dr. Yana Najjar, MD, Associate Professor in the Department of Medicine at the University of Pittsburgh and Director of the Clinical and Translational Research Center at UPMC Hillman Cancer Center. "Delivering VET3-TGI intravenously opens the door to using oncolytic virotherapy to treat patients with tumors that are not easily accessible for direct injection, expanding the potential reach of this therapeutic approach."

The continuation of IV dosing complements continued enrollment in the intratumoral (IT) arm of the Phase 1/1b trial, where patients are now being treated in cohort 3, and supports plans for combining VET3-TGI with checkpoint inhibitor therapy. The STEALTH-001 trial is evaluating VET3-TGI as both a monotherapy and in combination with a checkpoint inhibitor in patients with advanced, unresectable, or metastatic solid tumors.

"Systemic delivery of VET3-TGI is essential to realizing its full therapeutic potential, and this first IV dose brings us closer to that goal," said James Burke, MD, Chief Medical Officer of KaliVir Immunotherapeutics. "VET3-TGI was engineered to selectively infect tumor cells and deliver a potent combination of IL-12 and a TGFbeta inhibitor, stimulate a strong immune response and overcome tumor-driven immunosuppression. This milestone supports our broader goal of developing multi-mechanistic oncolytic immunotherapies that can address a wide range of solid tumors."

About VET3-TGI and the STEALTH-001 Study
VET3-TGI is a novel oncolytic virus developed using KaliVir’s proprietary VET platform. It is designed to selectively replicate in tumor cells, stimulate local immune responses, and remodel the immunosuppressive tumor microenvironment through the expression of IL-12 and a TGFβ inhibitor. The STEALTH-001 study is a first-in-human, open-label, dose escalation and expansion Phase 1/1b trial assessing both intratumoral and intravenous administration of VET3-TGI.VE

The STEALTH-001 trial is a dose escalation and expansion study evaluating VET3-TGI administered through direct IT injection and IV infusion. The trial is evaluating VET3-TGI as a monotherapy and in combination with a checkpoint inhibitor in patients with pathologically confirmed, advanced, unresectable or metastatic solid tumors. The study continues to progress as planned through its dose escalation phase.

On October 1, 2025 MiraDx, a molecular diagnostics company focused on genetic testing to personalize cancer treatment, reported that its PROSTOX ultra test is now available for ordering in the United States (Press release, MiraDx, OCT 1, 2025, View Source [SID1234656388]). The test, which helps identify localized prostate cancer patients at increased risk of developing side effects from stereotactic body radiation therapy (SBRT), has already helped over 3,500 patients as part of an Early Access Program involving select academic centers and private practices.

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PROSTOX ultra is a clinically validated genetic test that identifies patients with localized prostate cancer at higher risk of developing late genitourinary toxicity—urinary side effects such as urgency, leakage, or discomfort that may occur after treatment—with SBRT. SBRT delivers high doses of radiation over a short period of time, typically within 5-7 treatments. While SBRT is effective for treatment of prostate cancer, a subset of patients experience these side effects that present months or even years after treatment and can persist. By identifying patients with increased sensitivity to SBRT, PROSTOX ultra helps doctors and patients make more informed treatment decisions and consider alternative options when needed.

"Initial data from the PROSTOX Early Access Program in patients identified as having a high risk of toxicity to SBRT found that results from the test changed the course of treatment for 77% of these patients, helping them avoid potential complications from SBRT," said Melissa Stoppler, MD, Executive Vice President of Medical Affairs at MiraDx. "Extending access to this test to a broader range of clinicians and clinical settings will enable more prostate cancer patients to benefit from testing for these novel biomarkers of toxicity to radiation treatments."

PROSTOX ultra is a new and innovative test, and as such, coverage may vary depending on insurance plans. To ensure access, MiraDx is offering a Financial Assistance Program for patients, which provides reduced pricing based on household income.

On October 1, 2025 Ensem Therapeutics, Inc. (ENSEM) reported the U.S. Food and Drug Administration (FDA) granted Fast Track designation to its clinical stage pan mutant-specific allosteric PI3Kα inhibitor and degrader, ETX-636, for the treatment of adult patients with PIK3CA-mutant, hormone receptor positive (HR+)/human epidermal growth factor negative (HER2-) advanced breast cancer (Press release, ENSEM Therapeutics, OCT 1, 2025, View Source [SID1234656387]).

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ETX-636 was designed using ENSEM’s unique Kinetic Ensemble platform to optimally fit into a specific allosteric binding site in p110α, the catalytic subunit of PI3Kα and can selectively inhibit multiple activating mutant forms of PI3Kα, while sparing wildtype PI3Kα. The selectivity of ETX-636 for mutant PI3Kα greatly reduces the risk for hyperglycemia and other wildtype PI3Kα-related adverse events compared to non-mutant selective PI3Kα inhibitors. In addition, ETX-636 also leads to proteasome-dependent degradation of mutant PI3Kα, while sparing wildtype protein (a feature not seen with other pan-mutant allosteric inhibitors).

Activating mutations or alterations of the PI3Kα pathway are known to promote cancer cell growth and survival in a variety of tumor types, including breast cancer. In HR+/HER2- breast cancer (approximately 70% of all breast cancers), PIK3CA mutations are particularly prevalent, occurring in up to 40% of the cases.

"Patients with advanced HR+/HER2- breast cancer harboring PIK3CA mutations have poor prognosis, and there is an unmet need for therapies targeting this population that are safer and more efficacious than the current FDA approved non-mutant selective treatments," said Dr. Shengfang Jin, CEO and Co-Founder of ENSEM. "We are appreciative that the FDA has recognized ETX-636 as a potentially important treatment for this indication and we remain laser-focused on demonstrating its benefit to patients in our current clinical trials."

ETX-636 is currently being studied in an initial first-in-human, Phase 1/2 study which is evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of ETX-636 in participants with advanced solid tumors harboring a PIK3CA mutation. ETX-636 will be administered alone or in combination with fulvestrant, a selective estrogen receptor degrader approved for the treatment of advanced hormone receptor HR+/HER2- breast cancer NCT06993844.

Fast Track designation is a program provided by the FDA to expedite the development and review of drugs and biologics that treat serious conditions with unmet medical needs. It provides the opportunity for frequent and early communication and collaboration with the FDA, as well as the potential for accelerated approval and priority review eligibility to allow faster access to promising treatment to patients.