On October 13, 2025 FORE Biotherapeutics, a registration stage biotherapeutics company dedicated to developing targeted therapies to treat patients with cancer, reported it will host a virtual roundtable discussion with recognized key opinion leaders in oncology (Press release, Fore Biotherapeutics, OCT 13, 2025, View Source [SID1234656582]). The Fore-sponsored webcast event will take place on Wednesday, October 15, 2025, at 12:00 p.m. ET.

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"We are honored to bring together this distinguished group of medical oncology leaders to share their perspectives on the potential role of plixorafenib in monotherapy indications including BRAF V600 progressive or recurrent primary CNS tumors, solid tumors with BRAF fusions, and other BRAF altered tumors, including thyroid," said William Hinshaw, Chief Executive Officer of Fore. "This discussion reinforces our conviction in plixorafenib’s potential to make a meaningful difference in a patient population with very limited options."

The roundtable discussion will be moderated by William Hinshaw, Chief Executive Officer of Fore and will feature Stacie Peacock Shepherd, M.D., Ph.D., Chief Medical Officer of Fore, along with three recognized oncology experts:

Macarena De La Fuente, M.D., Chief of Neuro-Oncology, University of Miami Sylvester Comprehensive Cancer Center, Lead CNS Investigator, Phase 2 FORTE Trial
Eric Sherman, M.D., Head and Neck Medical Oncologist, Memorial Sloan Kettering Cancer Center
Patrick Y. Wen, M.D., Director, Center for Neuro-Oncology, Dana-Farber Cancer Institute, Professor of Neurology, Harvard Medical School
To access the webcast of the roundtable discussion go to the "Events" section or the homepage of the Company’s website or click here. An archived replay of the webcast will be available on the Company’s website beginning approximately two hours after the event.

About Plixorafenib

Plixorafenib is a novel BRAF inhibitor, with a unique mechanism of action that functions both as a dimer and paradox breaker, and that has demonstrated a differentiated and compelling monotherapy profile in clinical studies. In a previously conducted Phase 1/2 study, in patients with MAPK inhibitor naïve BRAF V600 primary recurrent CNS tumors (n=9), plixorafenib monotherapy demonstrated an ORR of 67% and a clinical benefit rate of greater than 75%. In patients with V600 alterations who were MAPK inhibitor naïve, plixorafenib achieved a 42% response rate with prolonged duration of response (mDOR 17.8 months), with a clinical benefit rate of >70%. Plixorafenib also demonstrated a favorable safety and tolerability profile across tumor types, including relative to existing standard of care treatments for various BRAF altered tumors, with a discontinuation rate due to drug-related adverse events of less than 2%. Fore Bio believes plixorafenib has the potential to overcome the limitations of currently available BRAF inhibitors through its unique mechanism of action targeting BRAF, while avoiding the limitations of the earlier generation BRAF inhibitors that led to rapid recurrence of disease and the need for combination with a MEK inhibitor.

On October 13, 2025 AbbVie (NYSE: ABBV) reported it will unveil new data from its robust antibody-drug conjugate (ADC) platform at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, taking place October 17-21, in Berlin, Germany (Press release, AbbVie, OCT 13, 2025, View Source [SID1234656598]). Data from investigational and approved ADCs across AbbVie’s portfolio such as telisotuzumab adizutecan (Temab-A),1-3 ABBV-706,4,5 and Emrelis (telisotuzumab vedotin),6 in patients with difficult-to-treat tumor types where there is urgent need for additional treatment options,7-15 will be featured in multiple presentations.

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"Despite recent progress in the treatment of advanced solid tumors, patients still face limited options and pressing unmet needs," said Daejin Abidoye, M.D., vice president, therapeutic area head, oncology, solid tumor and hematology, AbbVie. "The compelling data we are sharing at ESMO (Free ESMO Whitepaper) showcases how we are advancing targeted therapies across a range of solid tumors and highlights the potential of our portfolio."

Key highlights
AbbVie will present three oral presentations for Temab-A, a next-generation, investigational c-Met directed ADC with a novel topoisomerase 1 inhibitor (Top1i) payload. Phase 1 results with Temab-A both as a monotherapy and in combination across advanced, solid tumors will be presented:

Combination with bevacizumab (Bev) in Colorectal Cancer (CRC): In biomarker unselected patients with advanced CRC who have received three or more prior lines of therapy (NCT05029882), treatment with 2.4 mg/kg dose of Temab-A plus Bev (n=30) achieved an objective response rate (ORR) of 26.7% compared to an ORR of 0% with trifluridine/tipiracil with Bev (the current standard of care (SOC), n = 20).1 Grade ≥3 treatment emergent adverse events (TEAEs) occurred in 67% and 65% of patients, respectively.1
Monotherapy in MET-Amplified Solid Tumors: Among 100 patients with advanced MET-amplified solid tumors, including non-small cell lung cancer (NSCLC) (n=29), CRC (n=22), gastroesophageal adenocarcinoma (GEA) (n=14), and 16 other tumor types (n=35) who had progressed after SOC treatment (NCT05029882), Temab-A monotherapy achieved an ORR of 46% across all dose levels and tumor types with higher responses observed in patients with NSCLC (69%) and GEA (71%).2 The most common grade ≥3 TEAEs were anemia (40%) and neutropenia (34%).2
Monotherapy in Pancreatic Ductal Adenocarcinoma (PDAC ): Among 42 biomarker unselected patients with advanced/metastatic PDAC who experienced disease progression while receiving or after completing their first-line (1L) therapy (NCT06084481), Temab-A demonstrated an ORR of 24% overall and 40% in patients who received first-line gemcitabine-nab-paclitaxel treatment.3 Grade ≥3 TEAEs occurring in ≥10% of all patients were anemia (38%) and neutropenia (21%).3
"Temab-A continues to show meaningful clinical activity across an expanding range of solid tumors and patient populations, including patients with MET-amplification and increased c-Met expression as we have seen in previously presented data," said Vivek Subbiah, M.D., Chief, Early-Phase Drug Development, Sarah Cannon Research Institute and Temab-A investigator. "These data reinforce Temab-A’s potential in multiple solid tumors and thereby warrant its further clinical investigation."

AbbVie will also present new analysis from a Phase 1 study of ABBV-706, a SEZ6-directed ADC with a Top1i payload, in relapsed/refractory small cell lung cancer (R/R SCLC) (NCT05599984).

A post hoc analysis on data from R/R SCLC patients enrolled in the study, whose tumors had progressed after two lines of therapy (n=80), was done to compare the anti-cancer effect of ABBV-706 monotherapy vs. platinum-based SOC. All patients in this group had received the platinum-based SOC treatment as first-line therapy (1L SOC). Progression-free survival (PFS) during 1L SOC and PFS with ABBV-706 monotherapy as a subsequent line of treatment were analyzed in the same patients by paired Kaplan-Meier analysis. The findings suggest that ABBV-706 may have the potential to replace the platinum-based SOC as a first-line treatment in SCLC.4
In the same trial, ABBV-706 treatment also resulted in rapid clearance of circulating tumor DNA (ctDNA) and circulating tumor cells (CTC). Patients with 100% ctDNA clearance had significantly higher PFS and overall survival (OS) vs. patients without ctDNA clearance.5 These data highlight the potential of ctDNA as an early response marker in SCLC.5
A Phase 2 study assessing ABBV-706 in combination with atezolizumab as replacement of platinum-based chemotherapy is currently ongoing (NCT07155174) in 1L SCLC.

Details on key presentations at the ESMO (Free ESMO Whitepaper) 2025 Congress are available below and the full abstracts are available via the ESMO (Free ESMO Whitepaper) online program.

Title

Date/Time

Session

Abstract / Presentation Number

Telisotuzumab Adizutecan (ABBV-400; Temab-A) in
Patients With MET-Amplified Advanced Solid Tumors:
Results From a Phase 1 Study

Sunday,
October 19

2:45 – 4:15 PM
CEST

Oral presentation

Proffered paper
session:
Developmental
therapeutics

Room: Bremen
Auditorium – Hall
6.2

918O

Telisotuzumab Adizutecan (ABBV-400; Temab-A) in
Combination With Bevacizumab (Bev) in Patients (Pts)
With 3+ Colorectal Cancer (CRC): Dose Expansion
Results of a Phase 1 Study

Sunday,
October 19

2:45 – 4:15 PM
CEST

Mini oral session
1 : GI tumors,lower
digestive

Room:

Cologne Auditorium
– CityCube A

731MO

Phase 1 Basket Study of Telisotuzumab Adizutecan
(Temab-A), a c-Met Protein-Targeting Antibody-Drug
Conjugate (ADC): Results from Patients (Pts) With
Pancreatic Ductal Adenocarcinoma (PDAC)

Monday,
October 20

8:30 – 10:00
AM CEST

Mini oral session
2 : GI tumours,
upper digestive

Room: Bonn
Auditorium – Hall
7.1c

2214MO

Second progression-free survival (PFS2) and
subsequent treatment in patients (pts) with folate
receptor alpha (FR⍺)-positive platinum-resistant
ovarian cancer (PROC) treated with mirvetuximab
soravtansine (MIRV) vs. investigator’s choice
chemotherapy (ICC): Phase 3 MIRASOL trial

Saturday,
October 18

12:00 – 12:45
PM CEST

Poster

1068P

Efficacy of ABBV-706 as second-line treatment for
patients with platinum-refractory/resistant small cell
lung cancer

Saturday,
October 18

12:00 – 12:45
PM CEST

Poster

2777P

Real World Characteristics and Outcomes of Patients
with Third Line or Later Metastatic Colorectal Cancer:
Magnetic-101 Study Results

Sunday,
October 19

12:00 – 12:45
PM CEST

E-Poster

873eP

ABBV-706, a Seizure-Related Homolog Protein 6
(SEZ6)-Targeting Antibody-Drug Conjugate (ADC), in
Patients (Pts) With Relapsed/Refractory (R/R) Small
Cell Lung Cancer (SCLC): Circulating Biomarker and
Molecular Response Analyses

Saturday,
October 18

12:00 – 12:45
PM CEST

Poster

2778P

Seizure Related 6 Homolog (SEZ6) Expression
Pattern and Prognostic Impact in a Real-World Cohort
of Patients With Small Cell Lung Cancer

Saturday,
October 18

12:00 – 12:45
PM CEST

E-Poster

2796eP

Companion diagnostic assay for c-Met protein
overexpression (OE) to identify patients (pts) who may
benefit from telisotuzumab vedotin (Teliso-V)

Saturday,
October 18

12:00 – 12:45
PM CEST

Poster

1951P

Treatment outcomes in patients (pts) with advanced c-
Met overexpressing (OE) EGFR wildtype (WT)
nonsquamous (NSQ) NSCLC who had telisotuzumab
vedotin (Teliso-V) dose modifications in the
LUMINOSITY trial

Saturday,
October 18

12:00 – 12:45
PM CEST

Poster

1948P

Ocular surface disorders in patients with c-Met protein-
overexpressing NSCLC treated with telisotuzumab
vedotin in the LUMINOSITY study

Saturday,
October 18

12:00 – 12:45
PM CEST

Poster

1950P

METRIX: International Real-World Study of c-Met
Protein Overexpression in Patients With Advanced
/Metastatic NSCLC

Saturday,
October 18

12:00 – 12:45
PM CEST

Poster

1923P

Telisotuzumab adizutecan (Temab-A) and ABBV-706 are investigational medicines and are not approved by any health authorities worldwide. The safety and efficacy of these investigational medicines are under evaluation as part of ongoing clinical studies.

Elahere (mirvetuximab soravtansine) and Emrelis (telisotuzumab vedotin) are approved medicines being investigated for additional uses. Safety and efficacy have not been established for these unapproved additional uses.

Additional information on AbbVie clinical trials is available at View Source

On October 13, 2025 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:​HCM; HKEX:​13) reported results from the FRUSICA-2 registration clinical trial of the fruquintinib and sintilimab combination for the treatment of patients with locally advanced or metastatic renal cell carcinoma (Press release, Hutchison China MediTech, OCT 13, 2025, View Source [SID1234656583]). Results of the Phase III part of the study will be presented on Friday, October 17, 2025 during the European Society for Medical Oncology ("ESMO") Congress in Berlin, Germany.

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FRUSICA-2 is a randomized, open-label, active-controlled registration study evaluating the efficacy and safety of fruquintinib in combination with sintilimab versus axitinib or everolimus monotherapy for the second-line treatment of advanced renal cell carcinoma (NCT05522231). A total of 234 patients were randomized into a group that received fruquintinib plus sintilimab combination therapy, or into a group that received axitinib or everolimus monotherapy. As of the progression free survival ("PFS") final analysis cutoff of February 17, 2025, the median follow-up was 16.6 months.

The median PFS as assessed by blinded independent central review (BICR) was 22.2 months with fruquintinib plus sintilimab, compared to 6.9 months with axitinib/everolimus (stratified hazard ratio [HR] 0.373; stratified log-rank p<0.0001). The objective response rate (ORR) was 60.5% vs 24.3% (Odds Ratio 4.622, p<0.0001), and the median duration of response (DoR) was 23.7 vs 11.3 months, respectively. Overall survival data were still evolving at the time of data cutoff with maturity of approximately 20%. Efficacy benefits were observed in all prognostic risk groups, as defined by the International mRCC Database Consortium (IMDC) criteria.

The safety profile of the fruquintinib and sintilimab combination was tolerable and consistent with the known profiles of each individual treatment. Treatment-emergent adverse events (TEAEs) of grade 3 or above occurred in 71.4% of patients in the fruquintinib plus sintilimab group compared to 58.8% for patients in the axitinib/everolimus group.

"The FRUSICA-2 trial results provide compelling evidence that fruquintinib and sintilimab may offer a valuable new treatment option for patients with advanced renal cell carcinoma," said Professor Dingwei Ye of Fudan University Shanghai Cancer Center and the co-leading Principal Investigator of the FRUSICA-2 study. "These findings show the combination’s potential to address a critical unmet need for this patient population, delivering consistent benefits across varied patient profiles and prognostic risk groups."

"The FRUSICA-2 study suggests that fruquintinib and sintilimab could play a meaningful role in shaping second-line treatment strategies for advanced renal cell carcinoma," said Professor Zhisong He of Peking University First Hospital and the co-leading Principal Investigator of the FRUSICA-2 study. "These results point to the combination’s potential to enhance clinical outcomes, providing a new option for managing this challenging disease."

Supported by data from FRUSICA-2, a New Drug Application (NDA) for the combination of fruquintinib and sintilimab in patients with locally advanced or metastatic renal cell carcinoma who have failed prior treatment has been accepted for review by the China National Medical Products Administration (NMPA).

About Kidney Cancer and Renal Cell Carcinoma
It is estimated that approximately 435,000 new patients were diagnosed with kidney cancer worldwide in 2022.[1] In China, an estimated 74,000 new patients were diagnosed with kidney cancer in 2022.[2] Approximately 90% of kidney tumors are renal cell carcinoma.

The safety and efficacy of fruquintinib for the investigational uses discussed above have not been established and there is no guarantee that it will receive health authority approval or become commercially available in any country for the uses being investigated.

About Fruquintinib
Fruquintinib is a selective oral inhibitor of all three vascular endothelial growth factor receptors ("VEGFR") -1, -2 and -3. VEGFR inhibitors play a pivotal role in inhibiting tumor angiogenesis. Fruquintinib was designed to limit off-target kinase activity and improve drug exposure to achieve sustained target inhibition.[3]

Fruquintinib is co-developed and co-commercialized in China by HUTCHMED and Eli Lilly and Company under the brand name ELUNATE. It is approved for the treatment of patients with metastatic colorectal cancer who have previously received fluoropyrimidine, oxaliplatin and irinotecan-based chemotherapy, and those who have previously received or are not suitable to receive anti-VEGF therapy or anti-epidermal growth factor receptor (EGFR) therapy (RAS wild-type) in China. The combination of fruquintinib and sintilimab has received conditional approval in China for the treatment of patients with advanced pMMR endometrial cancer who have failed prior systemic therapy and are not candidates for curative surgery or radiation.

Takeda holds the exclusive worldwide license to further develop, commercialize, and manufacture fruquintinib outside mainland China, Hong Kong and Macau, marketing it under the brand name FRUZAQLA.

On October 13, 2025 Compugen Ltd. (NASDAQ: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in predictive computational target discovery powered by AI/ML, reported that pooled analysis of previously presented data, supporting the anti-tumor activity and safety profile of COM701 in heavily pre-treated patients with platinum resistant ovarian cancer (PROC), has been published as an abstract released by the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) (Press release, Compugen, OCT 13, 2025, View Source [SID1234656599]).

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The abstract focuses on a pooled analysis of 60 evaluable patients with platinum resistant ovarian cancer from prior COM701 Phase 1 clinical trials. The analysis characterizes the outcomes of patients who derived clinical benefit including progression free survival data. An additional year of follow-up will be included in the poster. The poster will be presented at ESMO (Free ESMO Whitepaper) in Berlin, Germany on October 18, 2025, by Oladapo Yeku, M.D., Ph.D., FACP, FASCO, Assistant Professor of Medicine, Harvard Medical School, and Director of Translational Research, Gynecologic Oncology Program, Massachusetts General Hospital, Boston, MA, and an investigator in Compugen’s ovarian cancer trials.

"The pooled analysis demonstrates that COM701 was well tolerated and showed consistent, durable responses in patients with heavily pretreated platinum-resistant ovarian cancer – particularly in those without liver metastases, representing patients with lower disease burden and potentially less immunosuppressive tumor microenvironment," said Dr. Oladapo Yeku. "The results of the analysis support the rationale for evaluating COM701 as maintenance therapy in earlier lines of treatment. I look forward to discussing this data along with the ongoing MAIA-ovarian trial in Berlin at ESMO (Free ESMO Whitepaper) on Saturday, October 18, 2025."

"There is a gap in care for women with platinum sensitive ovarian cancer who respond to chemotherapy but are ineligible for or cannot tolerate additional maintenance treatment," said Eran Ophir, Ph.D., President, and Chief Executive Officer of Compugen. "These patients have a less compromised immune system, providing the opportunity to harness the unique mechanism of action of COM701 to potentially change the disease trajectory and improve progression free survival. Compugen is currently conducting the MAIA-ovarian trial link assessing COM701 monotherapy as maintenance treatment in relapsed platinum-sensitive ovarian cancer."

Dr. Ophir added, "An interim analysis of the MAIA-ovarian trial is planned once data from approximately 60 participants enable assessment of median progression free survival. Sites have been activated in the U.S. and Israel. To further support enrollment, we recently initiated the activation of sites in France from the French oncology cooperative group ARCAGY-GINECO renowned for a number of recent platinum sensitive ovarian cancer trials. Based on the anticipated enrollment rate, the Company currently estimates interim analysis results at year end 2026. As we continue to focus on execution of our pipeline programs, we anticipate that our cash will support our operating plans well into 2027."

Access the Abstract

The abstract is now available on the publication section of Compugen’s website. The poster will be available on the publication section of Compugen’s website on Saturday October 18, 2025.

Additional ESMO (Free ESMO Whitepaper) Highlights

ESMO 2025 will also feature presentations from companies with differentiated Fc-reduced TIGIT programs, including two oral presentations from Compugen’s partner AstraZeneca with rilvegostomig- Fc reduced PD1/TIGIT bispecific, the TIGIT component of which is derived from Compugen’s clinical stage, COM902.

On October 13, 2025 Lupin Limited (Lupin) reported that it will present data from its Phase 1a clinical trial evaluating LNP3693, a STING agonist, at the ESMO (Free ESMO Whitepaper) Congress in Berlin, Germany, from October 17 to October 21, 2025 (Press release, Lupin, OCT 13, 2025, View Source [SID1234656584]). The presentation, titled "A phase 1 dose escalation study of LNP3693 (STING agonist) in patients with advanced or metastatic solid tumors & lymphoma," will be featured in the Investigational Immunotherapy session (Presentation Number 1553P). It can be viewed on October 19, 2025, from 09:00 to 17:00 CEST.

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LNP3693 is an investigational parenteral STING agonist. The presentation will provide qualitative insights into its safety, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity in patients with solid tumors.

"This marks another important milestone for us. Following our successful presentation of LNP7457, a PRMT5 inhibitor, at ASCO (Free ASCO Whitepaper) in June 2025, it is a privilege to present the findings of another Phase 1 clinical trial for LNP3693, a STING agonist, at ESMO (Free ESMO Whitepaper). ESMO (Free ESMO Whitepaper)’s acknowledgment of the clinical research conducted in India underscores the proficiency of our team in oncology drug discovery, research, and clinical development," said Vinita Gupta, CEO, Lupin.

Details of the Presentation:

Date and Time: Sunday, October 19, 2025, 09:00-17:00 (CEST)
Session Title: A Phase 1 Dose Escalation Study of LNP3693 (STING Agonist) in Patients with Advanced or Metastatic Solid Tumors & Lymphoma
Category: Investigational Immunotherapy
Clinical Trial Registration Number: CTRI/2023/10/059147
Presentation Number: 1553P
Complete data has been provided for presentation at the ESMO (Free ESMO Whitepaper) Congress 2025 and will be addressed during the official session.

All regular abstracts accepted for presentation at the ESMO (Free ESMO Whitepaper) Congress 2025 will be published online via the ESMO (Free ESMO Whitepaper) website on Monday, October 13, at 6:05 p.m. ET (12:05 a.m. CEST). All accepted abstracts will be published online in the ESMO (Free ESMO Whitepaper) Congress 2025 Abstract Book, a supplement to the official ESMO (Free ESMO Whitepaper) journal, Annals of Oncology.

More information regarding the ESMO (Free ESMO Whitepaper) Congress 2025 can be viewed at:
View Source