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Cogent Biosciences to Initiate New Drug Application (NDA) Submission for Bezuclastinib Under Real-Time Oncology Review (RTOR)

On January 20, 2026 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported that the U.S. Food and Drug Administration (FDA) has agreed to accept its New Drug Application (NDA) for bezuclastinib in combination with sunitinib for patients with Gastrointestinal Stromal Tumors (GIST) who have received prior treatment with imatinib under the Real-Time Oncology Review (RTOR) program.

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"This milestone reflects the FDA’s recognition of the significant unmet need facing patients with imatinib resistant GIST," said Andrew Robbins, Cogent’s President and Chief Executive Officer. "Based on positive results from the PEAK trial, the bezuclastinib combination has the potential to be the first new approval in this patient population in over 20 years. We look forward to the continued, close collaboration with the FDA as we advance bezuclastinib toward commercialization."

As announced in November 2025, the bezuclastinib combination in the PEAK trial demonstrated a substantial and highly statistically significant clinical benefit on the primary endpoint of progression free survival (PFS), reducing risk of disease progression or death compared to the current standard of care by 50% (hazard ratio of 0.50, 95% CI: 0.39 – 0.65). mPFS, as assessed by blinded independent central review, was 16.5 months for the bezuclastinib combination vs. 9.2 months for sunitinib monotherapy. Additionally, the bezuclastinib combination demonstrated an unprecedented overall response rate (ORR) in imatinib-resistant patients, with 46% of patients treated with the bezuclastinib combination achieving an objective response compared to 26% of patients treated with sunitinib. At the time of this analysis, data for overall survival remains immature.

The bezuclastinib combination was generally well tolerated, and no unique risks were observed with the novel combination when compared to the known safety profile of sunitinib.

The FDA’s RTOR program allows an applicant to pre-submit components of its NDA to allow the FDA to review clinical trial data before the complete filing is submitted and aims to provide a more efficient review process to ensure safe and effective treatments are available to patients as early as possible. Cogent is expected to initiate the RTOR process immediately with completion of the NDA submission expected in April 2026.

Full results from the PEAK trial will be presented at a major medical meeting during the first half of 2026. Additionally, Cogent expects to initiate in mid-2026 a Phase 2 trial investigating the benefit of the bezuclastinib combination for first-line GIST patients with exon 9 mutations who are naive to, or recently initiated treatment with, imatinib.

(Press release, Cogent Biosciences, JAN 20, 2026, View Source [SID1234662090])

Can-Fite Completes Patient Enrollment in Phase 2a Pancreatic Cancer Study of Namodenoson

On January 20, 2026 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a clinical-stage biotechnology company developing a pipeline of proprietary small molecule drugs for the treatment of cancer and inflammatory diseases, reported that patient enrollment has been completed in its Phase 2a pancreatic cancer clinical trial of Namodenoson.

The Phase 2a study is a multicenter, open-label trial enrolling patients with advanced pancreatic adenocarcinoma whose disease has progressed following at least one line of prior therapy. The study is evaluating the safety (primary endpoint), clinical activity, and pharmacokinetics (PK) of Namodenoson in this patient population. Participants receive oral Namodenoson at a dose of 25 mg, administered twice daily in continuous 28-day cycles. Patients are regularly monitored for safety, and to date, Namodenoson has demonstrated a favorable safety profile. The study is led by Prof. Salomon Stemmer, a renowned oncologist and key opinion leader at the Davidoff Center, Rabin Medical Center, Israel.

"This achievement marks a significant step forward in the clinical development of Namodenoson in pancreatic cancer," said Pnina Fishman, Ph.D., Chief Scientific Officer of Can-Fite BioPharma. "With enrollment now complete and safety continuing to be favorable, we believe we are well positioned to generate meaningful efficacy top-line data in Q3 2026."

Namodenoson is a highly selective A3 adenosine receptor (A3AR) agonist, which has shown a compelling safety profile and demonstrated anti-tumor activity in preclinical pancreatic cancer models. The drug is also being evaluated in clinical trials for advanced liver cancer.

Namodenoson has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer.

(Press release, Can-Fite BioPharma, JAN 20, 2026, View Source [SID1234662089])

Bristol Myers Squibb Announces Collaboration with Microsoft to Advance AI-Driven Early Detection of Lung Cancer

On January 20, 2026 Bristol Myers Squibb (NYSE: BMY, "BMS"), a global leader in oncology, reported an agreement with Microsoft, a market leader in AI-powered radiology and clinical workflow technologies, aiming to accelerate early detection of lung cancer.

Through this digital health collaboration, U.S. FDA-cleared radiology AI algorithms will be deployed via Microsoft’s Precision Imaging Network, part of Microsoft for Healthcare radiology solutions. Today, more than 80% of hospitals in the U.S. use Microsoft’s award-winning network to share medical imaging and access third-party imaging AI. AI capabilities available through Precision Imaging Network can automatically analyze X-ray and CT images to help identify lung disease, supporting radiologists in their daily workflow and helping reduce clinical workload. These advanced AI algorithms can help surface hard to detect lung nodules, potentially identify patients at earlier stages of lung cancer, and help triage them for appropriate care.

Lung cancer remains the leading cause of cancer-related deaths in the United States, with approximately 125,000 deaths and 227,000 new cases reported annually. Medically underserved populations experience even higher lung cancer mortality rates and are less likely to receive guideline-concordant screening. With more than half of the patients with incidental findings lost to follow-up, the collaboration leverages workflow management tools to track patients with lung nodules through care pathways and help ensure regular follow-up.

"By combining Microsoft’s highly scalable radiology solutions with BMS’ deep expertise in oncology and drug delivery, we’ve envisioned a unique AI-enabled workflow that helps clinicians quickly and accurately identify patients with Non-Small Cell Lung Cancer (NSCLC) and guide them to optimal care pathways and precision therapies," said Dr. Alexandra Goncalves, VP and Head of Digital Health, Bristol Myers Squibb. "An integrated, AI-powered platform that streamlines patient flow can significantly improve operational efficiency and patient outcomes."

A core objective of the collaboration is to expand access to early detection in medically underserved communities, including rural hospitals and community clinics across the United States. By harnessing advanced AI tools, especially in resource-limited settings, this initiative promotes earlier diagnosis and follow-up, enabling more equitable care for all patients.

"This new Microsoft collaboration reflects our commitment to breaking down barriers and addressing healthcare challenges," said Andrew Whitehead, VP and Head of Population Health, Bristol Myers Squibb. "At BMS, health equity is not a standalone initiative—it is embedded in everything we do. By deploying this solution and bringing advanced AI tools to the front lines, together we will help to address health disparities in lung cancer."

The early detection strategy for lung cancer directly supports BMS’ commitment to health equity and its focus on scalable, sustainable solutions to improve patient outcomes.

"With Microsoft’s AI-powered radiology technology platform widely deployed within healthcare delivery organizations across the country and operating behind the scenes, clinicians can more easily identify patients who may be showing early signs of cancer—often before they are aware of any symptoms—and help guide them into the appropriate care pathway sooner," said Peter Durlach, Corporate Vice President and Chief Strategy Officer, Microsoft Health and Life Sciences. "This is a clear win for both patients and providers and aligns with Microsoft’s goals to utilize technology to unlock insights, increase efficiencies, and improve patient care."

(Press release, Bristol-Myers Squibb, JAN 20, 2026, View Source [SID1234662088])

Jecho Bio Announces First Patient Dosed in Phase 1 Clinical Trial of JLM019 for Advanced Malignancies

On January 19, 2026 Jecho (Tianjin) Biopharmaceutical Co., Ltd. (hereinafter referred to as "Jecho Bio") reported that its independently developed innovative drug, JLM019, has successfully completed dosing of the first subject in a clinical trial for advanced malignant tumors at Peking Union Medical College Hospital.

JLM019 is a CD80/PD-1 dual-target Fc fusion protein with a unique bidirectional synergistic mechanism. With its precise targeting design, the drug is expected to overcome the limitations of existing immunotherapies, improve immunotherapy response rates, and delay the development of tumor cell resistance. As a result, it has the potential to significantly enhance immunotherapy and provide new treatment options and hope for survival for patients with advanced solid tumors and lymphomas.

This study is led by Professors Ba Yi and Han Xiaohong of Peking Union Medical College Hospital. The Phase 1 study is designed to evaluate the safety, tolerability, and preliminary efficacy of JLM019 injection in patients with advanced malignancies.

Jecho Bio remains committed to the development of innovative therapies to address unmet clinical needs and to promote the advancement of the biopharmaceutical industry. The company also looks forward to working closely with partners across the industry to accelerate the translation of innovative therapies into clinical practice and to jointly shape the future of the field.

(Press release, Jecho Laboratories, JAN 19, 2026, View Source [SID1234662130])

ENHERTU® Plus Pertuzumab Type II Variation Application Validated in the EU as First-Line Treatment of Patients with HER2 Positive Metastatic Breast Cancer

On January 19, 2026 The European Medicines Agency (EMA) reported that it has validated the Type II Variation marketing authorization application for ENHERTU (trastuzumab deruxtecan) in combination with pertuzumab for the first-line treatment of adult patients with unresectable or metastatic HER2 positive breast cancer.

ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/Nasdaq: AZN).

The validation confirms the completion of the application and commences the scientific review process by the EMA’s Committee for Medicinal Products for Human Use (CHMP). The application is based on data from the DESTINY-Breast09 phase 3 trial presented during a special late-breaking oral session at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (#ASCO25) Annual Meeting and subsequently published in The New England Journal of Medicine. In the trial, ENHERTU in combination with pertuzumab demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to taxane, trastuzumab and pertuzumab (THP) as a first-line treatment for patients with HER2 positive metastatic breast cancer.

"This validation in the EU is an important step in moving us closer to offering ENHERTU in combination with pertuzumab as a potential new first-line treatment option for patients with HER2 positive metastatic breast cancer," said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. "Following the recent approval in the U.S. for this indication, we look forward to working closely with the EMA to bring ENHERTU to eligible patients in the EU who may benefit from improved outcomes in a setting where the standard of care has not changed in more than a decade."

About DESTINY-Breast09
DESTINY-Breast09 is a global, multicenter, randomized, open-label, phase 3 trial evaluating the efficacy and safety of ENHERTU (5.4 mg/kg) either alone or in combination with pertuzumab versus standard of care THP as first-line treatment in patients with HER2 positive metastatic breast cancer.

Patients were randomized 1:1:1 to receive either ENHERTU monotherapy with a pertuzumab matching placebo; ENHERTU in combination with pertuzumab; or THP. Randomization was stratified by prior treatment (de novo metastatic disease versus progression from early-stage disease), hormone receptor (HR) status and PIK3CA mutation status.

The primary endpoint of DESTINY-Breast09 is PFS as assessed by blinded independent central review in both the ENHERTU monotherapy and ENHERTU combination arms. Secondary endpoints include investigator-assessed PFS, overall survival, objective response rate, duration of response, pharmacokinetics and safety. The investigational arm assessing ENHERTU monotherapy versus THP remains blinded to patients and investigators and will continue to the final PFS analysis.

DESTINY-Breast09 enrolled 1,157 patients across multiple sites in Africa, Asia, Europe, North America and South America. For more information about the trial, visit ClinicalTrials.gov.

About HER2 Positive Metastatic Breast Cancer
Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.1 More than two million breast cancer cases were diagnosed in 2022, with more than 665,000 deaths globally.1 In Europe, approximately 557,000 cases of breast cancer are diagnosed annually, with more than 144,000 deaths.1 While survival rates are high for those diagnosed with early breast cancer, only about 30% of patients diagnosed with or that have progressed to metastatic disease are expected to live five years following diagnosis.2

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors including breast cancer.3 HER2 protein overexpression may occur as a result of HER2 gene amplification.3 Approximately one in five cases of breast cancer are considered HER2 positive.4

HER2 positive metastatic breast cancer is an aggressive disease driven by overexpression or amplification of HER2 that affects 15% to 20% of patients with metastatic breast cancer.4 While HER2 targeted therapies have improved outcomes, prognosis remains poor with most patients experiencing disease progression within two years of first-line treatment with THP, which has been the standard of care for more than a decade.5,6,7 Further, approximately one in three patients do not receive any treatment following first-line therapy due to disease progression or death.8,9

About ENHERTU
ENHERTU (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki in the U.S. only) is a HER2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, ENHERTU is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca’s ADC scientific platform. ENHERTU consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

ENHERTU (5.4 mg/kg) in combination with pertuzumab is approved in the U.S. as a first-line treatment for adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+ or in-situ hybridization [ISH]+) breast cancer, as determined by an FDA-approved test, based on the results from the DESTINY-Breast09 trial.

ENHERTU (5.4 mg/kg) is approved in more than 90 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+ or ISH+) breast cancer who have received a prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial.

ENHERTU (5.4 mg/kg) is approved in more than 90 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial.

ENHERTU (5.4 mg/kg) is approved in more than 60 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 low (IHC 1+ or IHC 2+/ ISH-) or HER2 ultralow (IHC 0 with membrane staining) breast cancer, as determined by a locally or regionally approved test, that have progressed on one or more endocrine therapies in the metastatic setting based on the results from the DESTINY-Breast06 trial.

ENHERTU (5.4 mg/kg) is approved in more than 70 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 (ERBB2) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 and/or DESTINY-Lung05 trials. Continued approval in China and the U.S. for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ENHERTU (6.4 mg/kg) is approved in more than 80 countries/regions worldwide for the treatment of adult patients with locally advanced or metastatic HER2 positive (IHC 3+ or IHC 2+/ISH+) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01, DESTINY-Gastric02, DESTINY-Gastric04 and/or DESTINY-Gastric06 trials. Continued approval in China for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ENHERTU (5.4 mg/kg) is approved in more than 10 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02 trials. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

About the ENHERTU Clinical Development Program
A comprehensive global clinical development program is underway evaluating the efficacy and safety of ENHERTU as a monotherapy or in combination or sequentially with other cancer medicines across multiple HER2 targetable cancers.

(Press release, Daiichi Sankyo, JAN 19, 2026, View Source [SID1234662087])