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Pierre Fabre Laboratories receives CHMP positive opinion for BRAFTOVI® (encorafenib) in combination with cetuximab and FOLFOX (fluorouracil, leucovorin, and oxaliplatin) for the first-line treatment of adult patients with BRAFV600E-mutant metastatic colorectal cancer (mCRC)

On May 25, 2026 Pierre Fabre Laboratories reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending the approval of BRAFTOVI (encorafenib) in combination with cetuximab and FOLFOX for the first-line treatment of adult patients with BRAFV600E-mutant metastatic colorectal cancer (mCRC). The positive opinion will be submitted to the European Commission (EC) with a decision on EU marketing authorisation expected later this year.

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Eric Ducournau, Chief Executive Officer, Pierre Fabre Laboratories, said: "Today’s positive CHMP opinion marks an important step towards a targeted approach for patients with BRAFV600E-mutant metastatic colorectal cancer. If approved, it would be the only approved targeted therapy in the EU for this patient population in the first-line setting. This milestone reflects Pierre Fabre Laboratories’ commitment to advancing meaningful innovation in oncology and to working in close partnership with the scientific and medical community to address areas of high unmet need."

The CHMP positive opinion is based on results from the Phase 3 BREAKWATER trial which assessed the efficacy and safety of BRAFTOVI in combination with cetuximab and mFOLFOX6 in patients with previously untreated BRAFV600E-mutant mCRC, compared with oxaliplatin-based chemotherapy, with or without bevacizumab.

The regimen of BRAFTOVI in combination with cetuximab and mFOLFOX6 showed a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared with chemotherapy with or without bevacizumab (median PFS 12.8 vs. 7.1 months; hazard ratio [HR] 0.53; 95% confidence interval [CI], 0.41 to 0.68; P<0.001), and demonstrated a statistically significant improvement in the dual primary endpoint of ORR in the primary analysis set.

(Press release, Pierre Fabre, MAY 25, 2026, View Source [SID1234666038])

Menarini Group Announces New Data at the American Society of Clinical Oncology (ASCO) 2026 Annual Meeting

On May 25, 2026 The Menarini Group ("Menarini"), a leading international pharmaceutical and diagnostics company, and Stemline Therapeutics, Inc. ("Stemline"), a wholly-owned subsidiary of the Menarini Group, focused on bringing transformational oncology treatments to cancer patients, reported that new data related to elacestrant and tagraxofusp will be presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

New data exploring the safety and preliminary efficacy of elacestrant in combination with capivasertib in patients with ER+/HER2- PI3K/AKT/PTEN- pathway altered metastatic breast cancer (mBC) from the phase 1/2 ELEVATE study will be presented. Additional details on ongoing studies of elacestrant in combination, in the advanced setting, will be shared: ADELA (pivotal phase 3 combination with everolimus); ELECTRA (phase 1b/2 combination with abemaciclib in patients with brain metastases); and CAPELA (phase 2 combination with capecitabine). Lastly, an update from the ELEGANT study, exploring elacestrant as adjuvant treatment in node-positive early breast cancer with high risk of recurrence, will be presented at the congress.

Also accepted for presentation is new phase 2 tagraxofusp combination data in patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), which will be presented by Naveen Pemmaraju, MD, Professor, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center. Additionally, Stemline’s partner, Karyopharm Therapeutics, will present a late-breaking oral presentation from the phase 3 SENTRY trial of selinexor in JAKi naïve patients with myelofibrosis (MF). Selinexor is marketed in the U.S. by Karyopharm Therapeutics, and in the EU by Stemline.

"The extensive oncology data that will be presented, encompassing both solid tumors and hematologic malignancies, highlights our dedication to tackling the most difficult-to-treat cancers with high unmet needs," said Elcin Barker Ergun, CEO of the Menarini Group. "Our focus remains on accelerating innovation to provide transformational, targeted therapies that offer meaningful advances to patients and the healthcare communities dedicated to their care."

See below for full details of upcoming presentations:

2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting

Lead Author

Abstract Title and ID

Presentation

Details

Elacestrant

Wassim McHayleh

Elacestrant in combination with capivasertib in patients with
ER+/HER2- advanced breast cancer: Update from ELEVATE, a
phase 1b/2 open-label, umbrella study

Abstract: 1098

June 1, 2026; 1:30 – 4:30 PM CT

Poster Board 212

Aditya Bardia

ELEGANT: Elacestrant versus standard endocrine therapy in
women and men with node-positive, estrogen receptor-positive
(ER+), HER2-negative (HER2-), early breast cancer with high risk of
recurrence in a global, multicenter, randomized, open-label phase 3 study

Abstract: TPS1153

June 1, 2026; 1:30 – 4:30 PM CT

Poster Board 262a

Antonio Llombart-
Cussac

ADELA: A double-blind, placebo-controlled, randomized phase 3

trial of elacestrant + everolimus versus elacestrant + placebo in

ER+/HER2- advanced breast cancer patients with ESR1-mutated
tumors progressing on endocrine therapy + CDK4/6i*#

Abstract: TPS1154

June 1, 2026; 1:30 – 4:30 PM CT

Poster Board 262b

Nuhad Ibrahim

ELECTRA: An open-label multicenter, phase 1b/2 study of

elacestrant in combination with abemaciclib in patients with brain

metastasis from ER+/HER2- breast cancer

Abstract: TPS1155

June 1, 2026; 1:30 – 4:30 PM CT

Poster Board 263a

Kristina Fanucci

CAPELA: A phase II multicenter open-label randomized study of

capecitabine in combination with elacestrant versus capecitabine

alone in advanced estrogen receptor (ER)–positive breast cancer

(TBCRC 070)*

Abstract: TPS1156

June 1, 2026; 1:30 – 4:30 PM CT

Poster Board 263b

Tagraxofusp

Naveen Pemmaraju

A Phase II Trial of Tagraxofusp, Hyper-CVAD, and Venetoclax for

Patients with Newly Diagnosed or Relapsed/Refractory BPDCN*

Abstract: 6502

Oral Presentation

June 2, 2026; 10:09 – 10:21 am CT

Selinexor

John Mascarenhas

Selinexor plus ruxolitinib in JAK inhibitor–naïve myelofibrosis:

Phase 3 SENTRY trial*

Abstract: LBA6500

Oral Presentation

June 2, 2026; 9:45 am – 12:45 pm CT

*Denotes investigator sponsored research or collaborative research
#The ADELA study is a pivotal study co-sponsored with MEDSIR

About The Elacestrant Clinical Development Program
Elacestrant is also being investigated in several company-sponsored clinical trials in breast cancer disease, alone or in combination with other therapies. ELEGANT (NCT06492616) is a phase 3 trial evaluating the effectiveness of elacestrant versus standard endocrine therapy in women and men with node-positive, ER+, HER2- early breast cancer with high risk of recurrence. ADELA (NCT06382948) is a phase 3 randomized, double-blinded trial evaluating elacestrant in combination with everolimus in patients with ER+, HER2- mBC with ESR1-mut tumors. ELEVATE (NCT05563220) is a phase 1b/2 clinical trial evaluating the safety and efficacy of elacestrant combined with alpelisib, everolimus, capivasertib, palbociclib, ribociclib or abemaciclib. ELECTRA (NCT05386108) is an open-label phase 1b/2, multicenter study evaluating elacestrant in combination with abemaciclib in patients with ER+, HER2- breast cancer. The phase 2 portion evaluates this treatment regimen in patients with brain metastases. ELCIN (NCT05596409) is a phase 2 trial evaluating the efficacy of elacestrant in patients with ER+, HER2- advanced/metastatic breast cancer who received one or two prior hormonal therapies and no prior CDK4/6 inhibitors in the metastatic setting. Elacestrant is also being evaluated in additional investigator-led trials, in trials conducted in collaboration with other companies, in metastatic breast cancer as well as in early disease.

To report SUSPECTED ADVERSE REACTIONS, contact Stemline Therapeutics, Inc.
at [email protected]. All of the relevant information can be found at View Source

Full prescribing information for elacestrant can be found at View Source

Full prescribing information for selinexor can be found at View Source

Full prescribing information for tagraxofusp can be found at View Source

(Press release, Menarini, MAY 25, 2026, View Source [SID1234666036])

Entry into a Material Definitive Agreement

On May 24, 2026, Viridian Therapeutics, Inc. (the "Company") reported to have entered into a Commercial Manufacturing Services Agreement (the "Agreement") with WuXi Biologics (Hong Kong) Limited ("WuXi Biologics") pursuant to which WuXi Biologics will manufacture and supply the Company’s anticipated long-term supply requirements of veligrotug drug substance and drug product for commercial use (the "Product"), if approved. Wuxi Biologics will be a non-exclusive supplier of the Product to the Company and the Company may procure the Product from one or more alternate manufacturers of the Product.

Under the Agreement, the Company will provide rolling forecasts of volume requirements to WuXi Biologics on a monthly basis (each, a "Forecast"). A portion of each Forecast will be considered a binding and non-cancellable commitment of the Company. The parties have agreed to volume-based pricing under the Agreement. The Product service fee will remain fixed until December 31, 2026 and thereafter may be annually adjusted based on a volume-based structure. The Company will also reimburse WuXi Biologics for certain pass-through costs.

The Agreement has an initial term of five years and will automatically renew for successive five-year periods unless either party provides notice of non-renewal at least 24 months prior to the expiration of the initial term or any renewal period. The Company may terminate the Agreement upon 30 days’ prior notice to WuXi Biologics if there is a change in applicable laws that materially and adversely impacts WuXi’s Biologics ability to perform services under the Agreement. Additionally, each party may terminate the Agreement upon an uncured material breach of the Agreement by the other party or upon the other party’s insolvency or bankruptcy.

The Agreement contains customary provisions relating to, among other things, delivery, quality, change procedures, regulatory compliance, confidentiality, dispute resolution, warranties, and indemnification.

The foregoing description of the terms of the Agreement is not complete and is qualified in its entirety by reference to the text of the Agreement, a copy of which the Company intends to file as an exhibit to its Quarterly Report on Form 10-Q for the period ended June 30, 2026.

(Filing, Viridian Therapeutics, MAY 24, 2026, View Source [SID1234666059])

STORM Therapeutics to Present Promising Phase 1 Sarcoma Data Demonstrating Activity of First‑in‑Class METTL3 Inhibitor STC‑15 at ASCO 2026

On May 22, 2026 STORM Therapeutics Ltd. (STORM), the clinical stage company targeting RNA modifications to reprogram cells and develop novel cancer therapies, reported that a subset analysis of sarcoma patients enrolled in the Phase 1 dose escalation study of its lead candidate, STC-15, will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 29 – June 2, 2026 in Chicago, Illinois.

The presentation, titled ‘A Subset Analysis of Clinical Activity and Pharmacodynamic Biomarkers in Patients with Sarcomas in the Phase 1 Dose Escalation Study of STC-15, a METTL3 Inhibitor’, will report clinical activity alongside pharmacodynamic (PD) and epitranscriptomic findings from sarcoma patients treated with STC-15, a first-in-class, oral small-molecule inhibitor of the RNA methyltransferase METTL3.

The Phase 1 study enrolled 42 patients with advanced malignancies across five dose‑escalation cohorts ranging from 60 mg to 200 mg and evaluated both daily and three‑times‑weekly oral dosing regimens. Thirteen patients in the study had sarcomas and had received a mean of three prior lines of therapy.

Encouraging clinical activity in the sarcoma subset includes:

Evidence of clinical activity consistent with a differentiation‑driven mechanism of action, with disease control observed across multiple sarcoma subtypes
Disease control rate (DCR) of 54% at 12 weeks, including one confirmed partial response, and a median progression‑free survival of 6 months
Robust target engagement, demonstrated by an average >50% reduction in m6A (methylated adenosine) marks on mRNA within 24 hours of dosing across dose cohorts
Quantitative m6A and transcriptomic analyses providing supportive evidence of downstream effects on gene transcription, including RNA transcript changes associated with STC‑15 treatment
In patients who derived clinical benefit, decreased enrichment of genes associated with developmental pathways, consistent with modulation of biological processes linked to cancer stemness and aberrant differentiation, central to sarcoma pathology
Taken together, these data provide PD and transcriptional evidence linking METTL3 inhibition to modulation of gene expression pathways relevant to sarcoma biology, supporting the proposed mechanism of action of STC‑15.

Justin Moser, Associate Clinical Investigator at HonorHealth Research Institute and Associate Research Professor at Arizona State University John Shufeldt School of Medicine, said: "STC‑15 represents a novel, first-in-class approach to treating sarcoma by targeting RNA methylation to disrupt malignant progression. Early clinical activity, supported by biomarker evidence of target engagement and transcriptional modulation, supports further evaluation in this devastating disease with high mortality and limited treatment options."

Jerry McMahon, Chief Executive Officer of STORM Therapeutics, commented: "These data from the Phase 1 sarcoma subset provide encouraging early clinical and molecular evidence supporting STC‑15’s differentiation‑focused mechanism of action. Importantly, we observed a connection between target engagement, downstream transcriptional effects and signals of clinical benefit. For heavily pretreated sarcoma patients with limited treatment options, these results support our ongoing Phase 2 trial and highlight STC-15’s potential to transcriptionally reprogram tumor cells."

STC-15 represents a novel therapeutic approach in sarcoma by targeting RNA methylation to modulate aberrant epitranscriptomic programs that are central to sarcoma biology. In this Phase 1 sarcoma subset, STC-15 demonstrated robust target engagement with substantial reductions in m6A marks accompanied by downstream transcriptional changes. In patients who derived clinical benefit, these changes were associated with decreased enrichment of genes linked to developmental pathways that lead to cancer cell proliferation, mutation and spread.

These findings support the continued clinical evaluation of STC-15 in an ongoing Phase 2 study in selected sarcoma populations, assessing safety, pharmacokinetics, efficacy and exploratory biomarkers. STC-15 is also available to cancer patients under an Expanded Access Program.

Details of the poster presentation are as follows:

Poster Title: A Subset Analysis of Clinical Activity and Pharmacodynamic Biomarkers in Patients with Sarcomas in the Phase 1 Dose Escalation Study of STC-15, a METTL3 Inhibitor
Presenter: Justin C Moser, Associate Clinical Investigator at HonorHealth Research Institute, Scottsdale, AZ
Authors: Justin C Moser1, Jordi Rodon Ahnert2, Kyriakos P. Papadopoulos3, Yaara Ofir- Rosenfeld4, Josefin-Beate Holz4, Melinda Snyder4, Marguerite Hutchinson4, Kristen McCaleb4, Sean Uryu4, Ayush Raman5, Ananya Anmangandla5, Samantha M Carlisle6, Audrey Delgarno6, Laura Hover6, Ian Hoskins6, Gudrun Stengel5, Eric Martin4
Session Type/Title: Poster Session – Sarcoma
Date and Time: June 1, 2026, 1:30 PM-4:30 PM CDT
Location: Hall A – Posters and Exhibits
Abstract Number: 11548
Poster Board: 338

(Press release, STORM Therapeutics, MAY 22, 2026, View Source [SID1234666031])

OSE Immunotherapeutics Reports Positive Topline Results of TEDOVA Phase 2 Trial with Tedopi® in Recurrent Ovarian Cancer

On May 22, 2026 OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE), a clinical-stage biotech company dedicated to developing first-in-class therapies in immuno-oncology and immuno-inflammation, reported the release of the abstract selected for an oral presentation at the upcoming ASCO (Free ASCO Whitepaper) 2026Annual Meeting, unveiling topline results from the TEDOVA/GINECO-OV244b/ENGOT-ov58 academic, international, Phase 2 trial sponsored by ARCAGY-GINECO and evaluating Tedopi (OSE2101), with or without pembrolizumab, as a maintenance treatment in patients with platinum-sensitive recurrent ovarian cancer (PSOC).

Alexandra Leary, MD, PhD, Deputy Head of the Department of Medical Oncology at Gustave Roussy (Paris, France), oncologist specialising in gynaecological cancers, Chair of the GINECO group and Lead Investigator of the TEDOVA Phase 2 clinical trial of Tedopi, commented: "Ovarian cancer (OC) patients treated with platinum sensitive relapse post bevacizumab and PARP-inhibitors represent an unmet medical need with a progression free survival (PFS) of less than 3 months post platinum-based chemotherapy. In this difficult to treat setting, the combination of OSE2101 and pembrolizumab as maintenance significantly improved PFS. TEDOVA brings the 1st proof of concept for a vaccine strategy in OC, and actually the 1st positive trial in platinum sensitive OC in years!"

The TEDOVA Phase 2 trial enrolled 185 patients with PSOC who have progressed after or were ineligible for PARP inhibitors and bevacizumab. Patients with complete response, partial response, or stable disease after platinum-based therapy were randomized (1:1:2) to receive maintenance treatment with either best supportive care (control arm A), Tedopi monotherapy (arm B), or Tedopi in combination with pembrolizumab (arm C). The primary endpoint was progression-free survival (PFS) comparing Arm C vs Arm A. (NCT04713514)

The primary endpoint was met and results showed a statistically significant improvement in PFS for the combination of Tedopi and pembrolizumab compared to best supportive care (median PFS: 4.1 months vs 2.8 months; HR=0.53; p<0.001). When comparing the two investigational arms, the addition of pembrolizumab to Tedopi resulted in a 28% reduction in the risk of progression or death (HR=0.72, p=0.074).

The combination with pembrolizumab to Tedopi was associated with an increased incidence of adverse events, including immune-related events, consistent with the mechanism of action of immunotherapy.

These results will be presented on May 30, 2026, at the ASCO (Free ASCO Whitepaper) 2026 Annual Meeting in Chicago by Lead Investigator Alexandra Leary, MD, PhD.

In addition, OSE will be hosting a KOL webcast on June 10, 2026, to discuss how Tedopi could benefit patients affected by multiple oncology indications with key opinion leaders Stephen Liu, MD (MedStar Georgetown University Hospital), Benjamin Besse, MD (Gustave Roussy Institute, Paris) and Alexandra Leary, MD, PhD (Gustave Roussy Institute, Paris).

Marc Le Bozec, Chief Executive Officer, commented: "Thanks to the collaboration with ARCAGY-GINECO, these results provide further clinical evidence supporting the potential of Tedopi in difficult-to-treat cancers such as ovarian cancer. The data highlight both the clinical activity of Tedopi as monotherapy and its strong synergy in combination with anti-PD-1 therapy in heavily pretreated patients. These findings reinforce our strategy to advance Tedopi in Phase 3 development in non-small cell lung cancer, as well as in combination approaches through investigator-sponsored trials in ovarian, pancreatic, and lung cancers in collaboration with leading academic groups, with data expected through 2026."

KOL Webcast on Wednesday, June 10, 2026
6pm CET / noon ET

Live in English with optional French subtitles
Link to Webcast: http://bit.ly/4tMxhzG

(Press release, OSE Immunotherapeutics, MAY 22, 2026, View Source [SID1234666030])