On June 24, 2026 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) reported results from the pivotal Phase II registration study of fanregratinib (HMPL-453) in patients with intrahepatic cholangiocarcinoma ("ICC") will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Gastrointestinal Cancers Congress taking place from July 1 to 4, 2026 in Munich, Germany.

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Supported by data from the study, a New Drug Application (NDA) for fanregratinib for the treatment of adult patients with advanced, metastatic or unresectable ICC with fibroblast growth factor receptor ("FGFR") 2 fusion/rearrangement who have previously received systemic therapy has been accepted for review and granted priority review by the China National Medical Products Administration (NMPA) in December 2025.

"The clinical reality for this patient population with advanced FGFR2–fusion/rearrangement ICC is highly challenging, as the entire cohort had progressed on prior chemotherapy, and a significant majority had prior immunotherapy exposure," said Professor Jianming Xu of the Chinese PLA General Hospital and leading Principal Investigator of the study. "The results from this registration-enabling trial represent an important milestone in the targeted treatment landscape for FGFR2-altered ICC. The objective response rate and survival metrics achieved by fanregratinib clearly support its therapeutic value as a potent, selective oral treatment option. We are encouraged by these findings and hope to see this innovation translate into clinical practice to address a critical need in gastrointestinal oncology."

This pivotal study is a single-arm, multi-center, open-label, Phase II registration clinical trial conducted across 53 sites in China to evaluate the efficacy, safety and pharmacokinetic of fanregratinib in treating advanced ICC patients with FGFR2 fusion/rearrangement (NCT04353375). All patients had received at least one line of systemic therapy, of which all had received chemotherapy and 72% had received immunotherapy. The study has met its primary endpoint, demonstrating an Independent Review Committee (IRC)-assessed objective response rate (ORR) of 42.5% (95% CI: 30.0%–53.6%). Key secondary endpoints showed consistent clinical activity and a rapid onset of action, with a median time to response of 1.4 months. Median duration of response (DoR) was 6.9 months (95% CI: 5.6–8.5) and disease control rate (DCR) reached 83.9% (95% CI: 74.5%–90.9%). Furthermore, the median progression-free survival (PFS) was 6.9 months (95% CI: 4.1–8.2), while the median overall survival (OS) was 16.6 months (95% CI: 12.4–16.6).

Fanregratinib exhibited a manageable safety profile consistent with the known mechanism of selective FGFR inhibitors. Drug-related adverse events of Grade 3 or greater were reported in 48.3% of patients, with the most common being elevations in liver enzymes and palmar-plantar erythrodysesthesia syndrome (PPES). Treatment discontinuation due to drug-related adverse events was limited to 2.2% of patients, and no treatment-related deaths were recorded.

Details of the presentation are as follows:

Title: Fanregratinib in fibroblast growth factor receptor 2 (FGFR2)- fusions/​rearrangements intrahepatic cholangiocarcinoma (ICC): Pivotal part of a phase II trial
Lead Author: Jianming Xu, Chinese PLA General Hospital, Beijing, China
Session: Rapid oral session on innovation
Presentation Number: 343RO
Date & Time: Saturday, July 4, 2026, 9:00 am CEST
Location: Room 13a

About Fanregratinib

Fanregratinib (HMPL-453) is a novel, highly selective and potent inhibitor targeting FGFR 1, 2 and 3. Aberrant FGFR signaling has been found to be a driving force in tumor growth, promotion of angiogenesis and resistance to anti-tumor therapies. Abnormal FGFR gene alterations are believed to be the drivers of tumor cell proliferation in several solid tumor settings. HUTCHMED currently retain all rights to fanregratinib worldwide.

(Press release, Hutchison China MediTech, JUN 24, 2026, View Source [SID1234668945])

On June 24, 2026 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) reported results from the pivotal Phase II registration study of fanregratinib (HMPL-453) in patients with intrahepatic cholangiocarcinoma ("ICC") will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Gastrointestinal Cancers Congress taking place from July 1 to 4, 2026 in Munich, Germany.

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Supported by data from the study, a New Drug Application (NDA) for fanregratinib for the treatment of adult patients with advanced, metastatic or unresectable ICC with fibroblast growth factor receptor ("FGFR") 2 fusion/rearrangement who have previously received systemic therapy has been accepted for review and granted priority review by the China National Medical Products Administration (NMPA) in December 2025.

"The clinical reality for this patient population with advanced FGFR2–fusion/rearrangement ICC is highly challenging, as the entire cohort had progressed on prior chemotherapy, and a significant majority had prior immunotherapy exposure," said Professor Jianming Xu of the Chinese PLA General Hospital and leading Principal Investigator of the study. "The results from this registration-enabling trial represent an important milestone in the targeted treatment landscape for FGFR2-altered ICC. The objective response rate and survival metrics achieved by fanregratinib clearly support its therapeutic value as a potent, selective oral treatment option. We are encouraged by these findings and hope to see this innovation translate into clinical practice to address a critical need in gastrointestinal oncology."

This pivotal study is a single-arm, multi-center, open-label, Phase II registration clinical trial conducted across 53 sites in China to evaluate the efficacy, safety and pharmacokinetic of fanregratinib in treating advanced ICC patients with FGFR2 fusion/rearrangement (NCT04353375). All patients had received at least one line of systemic therapy, of which all had received chemotherapy and 72% had received immunotherapy. The study has met its primary endpoint, demonstrating an Independent Review Committee (IRC)-assessed objective response rate (ORR) of 42.5% (95% CI: 30.0%–53.6%). Key secondary endpoints showed consistent clinical activity and a rapid onset of action, with a median time to response of 1.4 months. Median duration of response (DoR) was 6.9 months (95% CI: 5.6–8.5) and disease control rate (DCR) reached 83.9% (95% CI: 74.5%–90.9%). Furthermore, the median progression-free survival (PFS) was 6.9 months (95% CI: 4.1–8.2), while the median overall survival (OS) was 16.6 months (95% CI: 12.4–16.6).

Fanregratinib exhibited a manageable safety profile consistent with the known mechanism of selective FGFR inhibitors. Drug-related adverse events of Grade 3 or greater were reported in 48.3% of patients, with the most common being elevations in liver enzymes and palmar-plantar erythrodysesthesia syndrome (PPES). Treatment discontinuation due to drug-related adverse events was limited to 2.2% of patients, and no treatment-related deaths were recorded.

Details of the presentation are as follows:

Title: Fanregratinib in fibroblast growth factor receptor 2 (FGFR2)- fusions/​rearrangements intrahepatic cholangiocarcinoma (ICC): Pivotal part of a phase II trial
Lead Author: Jianming Xu, Chinese PLA General Hospital, Beijing, China
Session: Rapid oral session on innovation
Presentation Number: 343RO
Date & Time: Saturday, July 4, 2026, 9:00 am CEST
Location: Room 13a

About Fanregratinib

Fanregratinib (HMPL-453) is a novel, highly selective and potent inhibitor targeting FGFR 1, 2 and 3. Aberrant FGFR signaling has been found to be a driving force in tumor growth, promotion of angiogenesis and resistance to anti-tumor therapies. Abnormal FGFR gene alterations are believed to be the drivers of tumor cell proliferation in several solid tumor settings. HUTCHMED currently retain all rights to fanregratinib worldwide.

(Press release, Hutchison China MediTech, JUN 24, 2026, View Source [SID1234668945])

On June 24, 2026 Revolution Medicines, a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, reported that four oral and poster presentations highlighting data from its RAS(ON) pipeline will be featured at the 2026 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Gastrointestinal Cancers Congress, taking place July 1–4, 2026 in Munich, Germany.

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The program will include two oral presentations from Phase 1/2 trials evaluating zoldonrasib, an oral RAS(ON) G12D-selective covalent inhibitor, in combination regimens for patients with metastatic RAS G12D pancreatic ductal adenocarcinoma (PDAC). These presentations will report results from zoldonrasib plus chemotherapy in the first line setting, and zoldonrasib plus daraxonrasib, the company’s oral RAS(ON) multi-selective inhibitor, in patients who had received one or more prior lines of therapy.

Additional presentations will include two Phase 3 trials-in-progress posters for RASolute 303, evaluating daraxonrasib as a monotherapy or in combination with gemcitabine and nab-paclitaxel versus standard of care gemcitabine and nab-paclitaxel as a first line treatment for patients with metastatic PDAC, and RASolute 304, evaluating adjuvant daraxonrasib in patients with PDAC who have undergone resection and completed perioperative chemotherapy.

Details of Revolution Medicines’ presentations are listed below.

Revolution Medicines Oral Presentations:

Title: Safety and Efficacy of Zoldonrasib (RMC-9805) Plus Chemotherapy in Patients (pts) with 1L RAS G12D Metastatic Pancreatic Adenocarcinoma (mPDAC)
Abstract: #340O
Presenter: Brian Wolpin, M.D., Dana-Farber Cancer Institute
Session: Proffered Paper Session
Date/Time: July 2; 2:40 p.m. – 2:50 p.m. CEST

Title: Safety and Efficacy of Zoldonrasib (RMC-9805) Plus Daraxonrasib (RMC-6236) in Patients with 2L+ KRAS G12D Metastatic Pancreatic Adenocarcinoma (mPDAC)
Abstract: #341O
Presenter: Nilofer Azad, M.D., Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Session: Proffered Paper Session
Date/Time: July 2; 2:50 p.m. – 3:00 p.m. CEST

Revolution Medicines Posters:

Title: RASolute 303: A Phase 3 Global, Multicenter, Open-Label, Randomized 3-Arm Study of Daraxonrasib Monotherapy or Daraxonrasib Plus Gemcitabine and Nab-paclitaxel Versus Gemcitabine and Nab-paclitaxel as a First Line Treatment for Patients With Metastatic Pancreatic Adenocarcinoma
Abstract: #471TiP
Presenter: Thomas Seufferlein, M.D., Ph.D., University Hospital Ulm
Session: Upper Digestive – Biliary, ampullary and pancreatic cancer
Date/Time: July 3; 3:30 p.m. – 4:30 p.m. CEST

Title: RASolute 304 – A Phase 3 Multicenter, Open-label, Randomized Study of Adjuvant Daraxonrasib Versus Observation Following Completion of Neoadjuvant and/or Adjuvant Chemotherapy in Patients With Resected Pancreatic Adenocarcinoma (PDAC)
Abstract: #472TiP
Presenter: Michel Ducreux, M.D., Ph.D., Institut Gustave Roussy
Session: Upper Digestive – Biliary, ampullary and pancreatic cancer
Date/Time: July 3; 3:30 p.m. – 4:30 p.m. CEST

(Press release, Revolution Medicines, JUN 24, 2026, View Source [SID1234668944])

On June 24, 2026 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported that Signatera has received regulatory approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).

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This approval supports the use of Signatera for patients with colorectal cancer (CRC) in the adjuvant setting and makes Signatera the first PMDA-approved MRD test in Japan. Natera expects to commercially launch Signatera for CRC in Japan by the end of 2026, subject to final pricing determination.

More than 150,000 people are diagnosed with CRC in Japan each year,1 making it one of the country’s most common cancers. This disease burden is comparable to that of the United States and highlights the need for more individualized tools to help Japanese clinicians inform adjuvant treatment decisions. Approval of Signatera fulfills this unmet need.

Commercialization of Signatera will be supported by an existing position statement from the Japan Society of Clinical Oncology (JSCO) and guidance from the Japanese Society of Medical Oncology (JSMO), which recommends the use of MRD testing in CRC.

"This approval marks an important milestone for Japanese patients with colorectal cancer," said Takayuki Yoshino, M.D., executive advisor to hospital director and director, department of global oncology, National Cancer Center Hospital East, chairman of JSCO, president of JSMO, and program director of the CIRCULATE-Japan Project. "Clinicians and medical societies in Japan deeply value the strength of the clinical evidence on Signatera, demonstrating its ability to inform treatment decisions."

Regulatory approval was supported by positive evidence from the GALAXY clinical trial, which demonstrated that patients who test MRD-positive after surgery derive significant benefit from adjuvant chemotherapy, while those who test MRD-negative derive no benefit from adjuvant chemotherapy. With analysis of 2,240 samples, this is one of the largest and most comprehensive prospective studies of MRD testing in resectable CRC and is part of the CIRCULATE-Japan platform involving thousands of CRC patients and >150 Japanese institutions.

"We are grateful to the investigators and patients who helped build the clinical evidence supporting this milestone," said Alexey Aleshin, M.D., corporate chief medical officer and general manager of oncology at Natera. "As we prepare for commercial launch in CRC, we remain committed to expanding global access to Signatera across additional cancer types, with muscle-invasive bladder cancer representing our next planned submission in Japan."

(Press release, Natera, JUN 24, 2026, View Source [SID1234668943])

On June 24, 2026 CEL-SCI Corporation (NYSE American: CVM) reported the successful conclusion of a formal signing ceremony with Saudi Amarox ("Amarox") during the BIO International Convention 2026 on June 22nd in San Diego, marking a significant step forward in U.S.–Saudi cooperation in healthcare innovation and oncology.

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The ceremony brought together executives from CEL-SCI and Amarox, along with representatives from Saudi healthcare, investment, and trade organizations, highlighting the growing partnership between the U.S. and the Kingdom of Saudi Arabia in advancing medical innovation and improving patient care.

Under the agreement, Amarox will support activities related to the planned introduction and commercialization of Multikine* in Saudi Arabia and potentially other counties in the region, subject to regulatory approvals.

"We are pleased to work with Amarox and our Saudi partners as Saudi Arabia continues to invest in healthcare innovation and advanced medical technologies," said Geert Kersten, Chief Executive Officer of CEL-SCI. "International collaboration has been central to CEL-SCI’s development strategy for many years, and we look forward to contributing our experience and expertise to support oncology care throughout the region."

CEL-SCI conducted the world’s largest Phase 3 trial in newly diagnosed advanced head and neck cancer, enrolling 928 patients across 23 countries, three continents, and approximately 100 clinical sites. The scale and geographic diversity of the study underscore CEL-SCI’s role as an international oncology innovator and its commitment to advancing cancer care through global scientific cooperation.

Abdullah Alzomaie, CEO and Founder of Amarox, commented, "Saudi Arabia is investing significantly in healthcare transformation and access to innovative medicines. We believe this collaboration supports those objectives while strengthening international partnerships that can help bring promising therapies to patients throughout the Kingdom and the broader region."

Saudi Arabia’s Vision 2030 initiative places significant emphasis on healthcare modernization, innovation, and international collaboration. The Kingdom has made substantial investments in healthcare infrastructure, biotechnology, pharmaceutical development, and research capabilities as it expands its regional center for advanced healthcare and life sciences.

About Multikine

Multikine is a cancer immunotherapy administered before surgery as a treatment for newly diagnosed previously untreated head and neck cancer. Its goal is to activate a person’s immune system to fight cancer before the ravages of surgery, radiation and chemotherapy have weakened the immune system. In the world’s largest head and neck cancer Phase 3 study, Multikine increased the 5-year survival rate of the target patient population to 73% vs 45% in patients treated with standard of care alone and halved the risk of death from 55% to 27%.

About Head and Neck Cancer

Head and neck cancer is the 6th most common cancer, with approximately 900,000 newly diagnosed cases per year globally. The newly diagnosed stage 3 and 4 patients with this cancer represent a severe unmet need.

(Press release, Cel-Sci, JUN 24, 2026, View Source [SID1234668942])