On July 25, 2025 Servier reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the approval of VORANIGO (vorasidenib) in the European Union (EU) for the treatment of predominantly non-enhancing Grade 2 astrocytoma or oligodendroglioma with an isocitrate dehydrogenase-1 (IDH1) R132 or isocitrate dehydrogenase-2 (IDH2) R172 mutation in adult and adolescent patients aged 12 years and older and weighing at least 40 kg who only had surgical intervention and who are not in immediate need of radiotherapy or chemotherapy (Press release, Servier, JUL 25, 2025, View Source [SID1234654535]).

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The marketing authorization application for VORANIGO will now be reviewed by the European Commission (EC), which has the authority to approve medicines for use in the 27 member states of the EU. Decisions by the EC are also applicable in Norway, Liechtenstein, and Iceland.

"Today’s recommendation for EU approval brings us one step closer to offering VORANIGO to patients in the EU with Grade 2 IDH-mutant glioma who have historically had limited treatment options for this relentless disease," said Susan Pandya, M.D., Vice President Clinical Development and Global Head of Oncology LS/LCM, Servier. "We look forward to continuing conversations with the EMA and other regulatory bodies around the world to introduce VORANIGO as a potential new standard of care for patients with IDH-mutant gliomas."

The CHMP opinion is based on the positive results of the Phase 3 INDIGO trial, a global Phase 3 randomized, double-blind placebo-controlled study of vorasidenib in patients with residual or recurrent Grade 2 glioma with an IDH1/2 mutation who have undergone surgery as their only treatment. Results were presented during the plenary session at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and published simultaneously in The New England Journal of Medicine.

VORANIGO was approved by the United States Food and Drug Administration (FDA) in August 2024 after being granted Fast Track, Breakthrough and Orphan Drug Designations and receiving Priority Review. VORANIGO has also been granted marketing authorization in Canada, Australia, Israel, the United Arab Emirates, Saudi Arabia, and Switzerland. Servier has also submitted marketing authorization applications in the United Kingdom, Japan and various other regions, and reviews by the appropriate health authorities are ongoing.

The use of VORANIGO is investigational in the EU and is not yet approved.

On July 25, 2025 Taiho Oncology, Inc., a company developing and commercializing novel treatments for hematologic malignancies and solid tumors, reported it will present new data from the REZILIENT2 trial of zipalertinib at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025, to be held Oct. 17-21, 2025, in Berlin, Germany (Press release, Taiho, JUL 25, 2025, View Source [SID1234654536]).

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The abstract accepted for a mini oral presentation includes the preliminary efficacy and safety data from the Phase 2b REZILIENT2 trial of zipalertinib, an oral, highly selective, irreversible EGFR tyrosine kinase inhibitor (TKI), in patients with advanced or metastatic NSCLC harboring EGFR ex20ins mutations or EGFR uncommon non-ex20ins mutations and active brain metastases and/or leptomeningeal disease.

"We look forward to presenting the latest findings from Cohort C of our REZILIENT2 trial, which focuses on a subset of patients with ex20ins NSCLC with central nervous system involvement, at this year’s ESMO (Free ESMO Whitepaper) Congress," said Harold Keer, MD, PhD, Chief Medical Officer, Taiho Oncology. "We are excited to share more details from our zipalertinib program, building upon its potential to make a meaningful impact in a disease area of unmet need."

The session title and information for the accepted abstract are listed below. Full abstract details will be available via the conference website at 12:05 CEST a.m. on Oct. 13, 2025.

Title: Activity of Zipalertinib Against Active Central Nervous System (CNS) Metastases in Patients With Non-Small Cell Lung Cancer (NSCLC) Harboring EGFR Exon 20 Insertion (Ex20ins)/Other Uncommon Mutations
Abstract Number: 3778
Session Name: Mini oral session 1: NSCLC metastatic
Session Type: Mini Oral Presentation
Session Date: Oct. 19, 2025
Session Time: 8:30 to 10 a.m. CEST

About Zipalertinib
Zipalertinib (development code: CLN-081/TAS6417) is an orally available small molecule designed to target activating mutations in EGFR. The molecule was selected because of its ability to inhibit EGFR variants with exon 20 insertion mutations, while sparing wild-type EGFR. Zipalertinib is designed as a next generation, irreversible EGFR inhibitor for the treatment of a genetically defined subset of patients with non-small cell lung cancer. Zipalertinib has received Breakthrough Therapy Designation from the FDA. Zipalertinib is investigational and has not been approved by any health authority.

Zipalertinib is being developed by Taiho Oncology, Inc., its parent company, Taiho Pharmaceutical Co., Ltd., and in collaboration with Cullinan Therapeutics, Inc. in the U.S.

On July 25, 2025 Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology, reported that four abstracts highlighting clinical progress across its botensilimab and balstilimab immunotherapy programs have been accepted for presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025, taking place in Berlin, Germany from October 17-21 (Press release, Agenus, JUL 25, 2025, View Source [SID1234654537]). The highlight is an oral presentation that will feature emerging survival plateaus from a study of botensilimab plus balstilimab in 343 evaluable patients with refractory metastatic solid tumors across five tumor types. Three additional poster presentations will feature data from investigator-sponsored studies in cervical cancer, MSS metastatic colorectal cancer (mCRC), and non-melanoma skin cancers, underscoring the broad potential of botensilimab and balstilimab based combinations in difficult-to-treat cancers.

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Presentation Details:

1. Oral Presentation Title: Emerging survival plateaus with botensilimab and balstilimab: Pan tumor data from a large phase 1b trial of advanced solid tumors

Presenting Author:
Dr. Michael Gordon; HonorHealth Research Institute-AZ, USA

Mini Oral Session:

Investigational Immunotherapy

Session Date:

Friday, October 17, 2025

Session Time:

2:00-3:00 PM CEST / 8:00-9:30 AM EDT

Location:

Hall 5.2

Abstract Number:

3220

2.

Poster Presentation Title: Efficacy and safety of balstilimab with or without zalifrelimab in recurrent cervical cancer: Results from the global phase 2 RaPiDs trial

Presenting Author: Dr. David O’Malley; The Ohio State University Comprehensive Cancer Center- OH, USA
Session Date:

Saturday, October 18, 2025

Session Time:

12:00-12:45 PM CEST / 6:00-6:45 AM EDT

Location:

Hall 25

Abstract Number:

2952

Poster Number:

1164P

3.

Presentation Title: A Phase I trial of botensilimab, balstilimab and regorafenib (BBR) in chemotherapy-resistant patients with microsatellite stable (MSS) metastatic colorectal cancer

Presenting Author:

Dr. Marwan Fakih; City of Hope- CA, USA

Session Date:

Sunday, October 19, 2025

Session Time:

12:00-12:45 PM CEST / 6:00-6:45 AM EDT

Location:

Hall 25

Abstract Number:

6197

Poster Number:

851P

4.

Presentation Title: A phase 2, open label study to evaluate the safety and clinical activity of balstilimab in patients with advanced/metastatic non-melanoma skin cancers (AGENONMELA)

Presenting Author:

Dr. Iwona Lugowska; Maria Sklodowska-Curie National Research Institute and Oncology Center – Poland

Session Date:

Monday, October 20, 2025

Session Time:

12:00-12:45 PM CEST / 6:00-6:45 AM EDT

Location:

Hall 25

Abstract Number:

7273

Poster Number:

1662P

On July 25, 2025 Alligator Bioscience (Nasdaq Stockholm: ATORX), a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs, reported that data from the Phase 1 REACtiVe-2 trial (NCT05650918) of the CD40 agonist mitazalimab in combination with dendritic cell vaccination (Amphera’s MesoPher) will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025, taking place on 17–21 October in Berlin, Germany (Press release, Alligator Bioscience, JUL 25, 2025, View Source [SID1234654521]).

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The study, led by Erasmus MC Cancer Institute, evaluated the safety, tolerability, and immunologic activity of mitazalimab in combination with MesoPher following chemotherapy with mFOLFIRINOX in patients with metastatic pancreatic cancer. The data will be presented in a poster entitled "REACtiVe-2: Phase I Evaluation of Dendritic Cell Vaccination and Agonistic CD40 Therapy Following (m)FOLFIRINOX in Metastatic Pancreatic Cancer".

On July 25, 2025 Evaxion A/S (NASDAQ: EVAX) ("Evaxion"), a clinical-stage TechBio company specializing in developing AI-Immunology powered vaccines, reported it will be presenting two-year clinical efficacy data from its phase 2 trial with lead compound EVX-01 at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025 to be held in Berlin, Germany, from October 17-21, 2025 (Press release, Evaxion Biotech, JUL 25, 2025, View Source [SID1234654522]).

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Designed with Evaxion’s AI-Immunology platform, EVX-01 is a personalized cancer vaccine currently being evaluated as a treatment for advanced melanoma (skin cancer). The trial has yielded numerous convincing data already, including interim one-year data presented at the ESMO (Free ESMO Whitepaper) Congress in September 2024. Data demonstrated a 69% Overall Response Rate, reduction in tumor target lesions in 15 out of 16 patients, and a positive correlation between the AI-Immunology platform predictions and immune responses induced by the individual neoantigens in the EVX-01 vaccine (p=0.00013).

"We are delighted to have the two-year data from the EVX-01 phase 2 trial accepted for presentation at the ESMO (Free ESMO Whitepaper) Congress 2025. As one of the most important and prestigious medical oncology conferences in the world, the congress will be a great place for us to present the data to a large audience, including potential partners," says Birgitte Rønø, CSO and interim CEO of Evaxion.

The phase 2 trial investigates EVX-01 in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in patients with advanced melanoma (skin cancer). Each patient enrolled in the trial has received a unique vaccine designed and manufactured based on their individual biology. KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

Presentation details

Abstract Title: EVX-01, a personalized cancer vaccine, induces potent T-cell responses and durable disease control in advanced melanoma: 2-year follow-up
Abstract#: #6308
Presentation#: 1516MO
Track: Mini oral session: Investigational immunotherapy
Location: Nuremberg Auditorium – Hall 5.2
Date/Time: October 17 at 14:10 – 14:15 CEST
Presenter: Dr. Muhammad Adnan Khattak, Director, Oncology, One Clinical Research, Hollywood Private Hospital & Edith Cowan University, Perth, WA, Australia
About EVX-01

EVX-01 is a personalized peptide-based cancer vaccine intended for first-line treatment of multiple advanced solid cancers. It is Evaxion’s lead clinical asset.

EVX-01 is a personalized therapy designed with our AI-Immunology platform and is tailored to target the unique tumor profile and immune characteristics of each patient. It engages the patient’s immune system to fight off cancer by mounting a targeted response against tumors.

In the completed phase 1/2a clinical trial (NCT03715985), assessing EVX-01 in combination with a PD-1 inhibitor, eight of twelve metastatic melanoma patients (67%) had objective clinical responses, with two complete and six partial responses.

In addition, vaccine-induced T cells were detected in all patients and a significant correlation between clinical response and the AI-Immunology predictions was observed, underlining the predictive power of the platform.