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Clinical Trial News

Neoadjuvant Nivolumab Plus Chemotherapy Demonstrates 10% Survival Advantage in Resectable NSCLC at 5-Year Follow-up

  • The CheckMate 816 phase 3 trial demonstrates that patients with resectable non-small cell lung cancer who received nivolumab plus chemotherapy before surgery had approximately 10% higher survival rates at 5 years compared to chemotherapy alone.
  • Among the 24% of patients achieving pathologic complete response with the combination therapy, no patient died from lung cancer by 5 years, highlighting the potential for cure in this subset.
  • The findings led to global regulatory approval of neoadjuvant nivolumab plus chemotherapy as standard treatment for eligible patients, including in Ireland.
  • The NeoCOAST-2 trial results published in Nature Medicine suggest that adding antibody drug conjugates to standard chemo-immunotherapy may further improve pathologic response rates.

"Study of chemotherapy vs immunotherapy for patients with lung cancer bounded in the thorax and completely resected"

2024-513730-38-00Active, Not RecruitingPhase 3
Fundacion GECP

DLL3-Targeted CAR-T Therapy LB2102 Shows Promise in Relapsed/Refractory Small Cell Lung Cancer

CAR-T
  • LB2102, a DLL3-directed autologous CAR-T cell therapy, demonstrated preliminary antitumor activity with a 16.7% objective response rate and 66.7% disease control rate in patients with relapsed/refractory small cell lung cancer and large cell neuroendocrine carcinoma.
  • The phase 1 dose-escalation trial found no dose-limiting toxicities up to dose level 4, with responses deepening at higher dose levels, supporting continued dose escalation.
  • Treatment-related adverse events were manageable, with only mild cytokine release syndrome observed in 2 patients and no deaths due to adverse events reported in the study.

Sutro Biopharma Appoints Greg Chow as CFO to Advance ADC Pipeline

Oncology
  • Sutro Biopharma appointed Greg Chow as Chief Financial Officer effective June 2, 2025, bringing over 25 years of executive leadership experience in biotech finance and operations.
  • Chow previously served as CFO at multiple biotech companies including Freenome Holdings and Frontier Medicines, where he guided major financing rounds and strategic collaborations.
  • The appointment aims to strengthen Sutro's financial position as the company advances its pipeline of novel exatecan-based and dual-payload antibody drug conjugates through clinical milestones.
  • Sutro granted Chow equity compensation including 100,000 restricted stock units and options for 275,000 shares under the company's 2021 Equity Inducement Plan.

Instil Bio Appoints Veteran Oncologist Jamie Freedman as Chief Medical Officer to Advance PD-L1xVEGF Bispecific

Oncology
  • Instil Bio has appointed Jamie Freedman, M.D., Ph.D., as Chief Medical Officer to lead development of AXN-2510, a novel PD-L1xVEGF bispecific antibody for solid tumors.
  • Dr. Freedman brings over 20 years of biopharmaceutical leadership experience and has contributed to 15 drug approvals across multiple therapeutic areas.
  • The appointment strengthens Instil Bio's clinical leadership as the company advances AXN-2510, which Dr. Freedman believes has potential to redefine standard of care for solid tumors.

Lilly's Next-Generation ADC Shows 55% Response Rate in Platinum-Resistant Ovarian Cancer

Oncology
  • Eli Lilly's investigational folate receptor alpha-targeting ADC LY4170156 demonstrated a 55% overall response rate at the recommended Phase 2 dose in heavily pre-treated platinum-resistant ovarian cancer patients.
  • The therapy showed anti-tumor activity across all folate receptor alpha expression levels, including in patients previously treated with mirvetuximab soravtansine, addressing a significant unmet medical need.
  • The Phase 1 study enrolled 95 patients who received a median of five prior systemic regimens, with encouraging safety profile and no treatment-emergent neuropathy or ocular toxicity observed.
  • Lilly plans to rapidly advance the compound into registrational Phase 3 clinical trials based on these promising initial results presented at the 2025 ASCO Annual Meeting.

A Study of LY4170156 in Participants With Selected Advanced Solid Tumors

NCT06400472RecruitingPhase 1
Eli Lilly and Company
Posted 5/20/2024

Oxford Cancer Biomarkers Partners with Mira Precision Health to Advance ToxNav® Test for 5FU/Capecitabine Toxicity Prediction in US Market

Precision Medicine
  • Oxford Cancer Biomarkers has partnered with Mira Precision Health to advance its ToxNav® test in the United States, a precision oncology diagnostic that identifies patients at high risk of severe toxicity from 5FU/capecitabine treatment.
  • The ToxNav® test enhances clinical decision-making through comprehensive genetic profiling and aligns with recent NCCN Guidelines updates recommending DPYD testing for colorectal cancer patients receiving fluoropyrimidine-based treatments.
  • The partnership aims to establish substantial market presence in the US, with ToxNav® already backed by multiple peer-reviewed studies and CE-IVD certification in the UK, potentially saving patient lives by preventing avoidable treatment toxicity.

SWOG S2302 Pragmatica-Lung Trial Fails to Show Survival Benefit but Sets New Standard for Streamlined Cancer Research

Monoclonal Antibody
  • The SWOG S2302 Pragmatica-Lung trial found that ramucirumab plus pembrolizumab combination did not significantly extend overall survival compared to standard care in advanced non-small cell lung cancer patients.
  • The phase 3 study achieved rapid enrollment of 838 patients with exceptional diversity, including 22% non-White individuals and 15% from rural areas, demonstrating the effectiveness of pragmatic trial design.
  • Despite negative efficacy results, the trial established a paradigm-shifting model for future cancer research by completing development in 200 days and enrollment in 21 months.
  • The investigational combination may serve as a viable non-chemotherapy alternative with comparable efficacy but potentially different toxicity profile for some patients.

Dyadic International Appoints Joe Hazelton as President to Lead Strategic Pivot to Ancillary Protein Markets

Leadership Change
  • Dyadic International has appointed Joe Hazelton as President to accelerate its strategic shift toward revenue-generating ancillary recombinant protein products for life sciences, nutrition, and industrial markets.
  • The company has achieved commercial validation through key partnerships including a develop-and-commercialize agreement with Proliant Health and Biologicals for recombinant human albumin and a joint venture with Fermbox Bio launching EN3ZYME.
  • Dyadic's C1 and Dapibus™ platforms continue to underpin the company's strategy, offering large-scale, high-titer production of recombinant proteins across non-therapeutic markets.
  • The leadership realignment positions Dyadic to capitalize on geopolitical trends driving reshoring of biomanufacturing supply chains to the United States and allied countries.

Viz.ai Partners with Novartis to Develop AI-Powered Cancer Care Solutions for Prostate and Breast Cancer

AIOncologyPrecision Medicine
  • Viz.ai and Novartis announced a multi-year strategic collaboration to develop AI-powered workflows within the Viz Oncology Suite, focusing on prostate and breast cancer patient identification and care coordination.
  • The partnership will create two new solutions: Viz Prostate Cancer to streamline patient identification for guideline-based treatments, and Viz Breast Cancer to automate patient review and facilitate multidisciplinary care coordination.
  • The collaboration addresses critical gaps in cancer care, as only one in four prostate cancer patients receive guideline-recommended therapy, while breast cancer remains the most widely diagnosed cancer in the United States with complex care journeys.
  • This strategic alliance marks Viz.ai's expansion into oncology, building on their AI-powered disease detection platform that currently serves over 1,700 hospitals and health systems across the U.S. and Europe.

Outlook Therapeutics Launches First Approved Ophthalmic Bevacizumab in Europe for Wet AMD Treatment

Monoclonal AntibodyDrug Approval
  • Outlook Therapeutics has commercially launched LYTENAVA™ (bevacizumab gamma) in Germany and the UK, marking the first and only approved ophthalmic formulation of bevacizumab for wet AMD treatment in Europe.
  • The launch addresses a significant market need, with approximately 2.8 million injections of repackaged off-label bevacizumab administered annually in Europe for retinal diseases.
  • LYTENAVA™ has potential to mitigate certain risks associated with current off-label use of repackaged bevacizumab, while the company plans additional European launches throughout 2025 and 2026.
  • The company has partnered with Cencora to support global commercial distribution and market access, with a BLA resubmitted to the FDA for potential U.S. approval.

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