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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.

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.

ImmunAbs Receives FDA Clearance for Phase 2 Trial of IM-101 Complement Inhibitor in Myasthenia Gravis

Monoclonal AntibodyFDA ApprovalRare Disease
  • ImmunAbs Inc. announced FDA clearance of its IND application to initiate a Phase 2 clinical trial evaluating IM-101, a novel complement C5 inhibitor, for treating Myasthenia Gravis.
  • The multicenter, randomized, double-blind, placebo-controlled study will enroll up to 90 patients to assess monthly IM-101 dosing effectiveness and safety.
  • IM-101 demonstrated excellent safety profile in Phase 1 trials with no dose-limiting toxicity and superior efficacy in complement inhibition compared to existing treatments.
  • The company believes comprehensive inhibition of both classical and alternative complement pathways is essential for achieving deeper therapeutic responses in MG patients.

NICE Recommends Eli Lilly's Mirikizumab for Crohn's Disease Treatment Following Positive Phase 3 Trial Results

Drug ApprovalMonoclonal Antibody
  • The National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending mirikizumab (Omvoh) for adults with moderately to severely active Crohn's disease who have not responded to or cannot tolerate previous biological treatments.
  • Phase 3 VIVID-1 trial results demonstrated that 45% of mirikizumab-treated patients achieved clinical remission at one year compared to 20% on placebo, with 38% showing visible intestinal healing versus 9% on placebo.
  • The recommendation comes less than two months after UK regulatory approval, with the treatment targeting interleukin-23p19 protein to reduce gastrointestinal inflammation in patients with this lifelong condition affecting over 200,000 people in the UK.

MHRA Approves Serplulimab as First Anti-PD-1 Therapy for Small Cell Lung Cancer in UK

Monoclonal AntibodyDrug ApprovalOncology
  • The UK's Medicines and Healthcare products Regulatory Agency approved serplulimab (Hetronifly) as the first anti-PD-1 monoclonal antibody for treating extensive-stage small cell lung cancer.
  • Clinical trial data showed patients receiving serplulimab with chemotherapy lived an average of 15.4 months compared to 10.9 months with chemotherapy alone.
  • The approval provides a new treatment option for an aggressive cancer type that accounts for 10-15% of lung cancer cases and typically has poor prognosis.
  • Serplulimab is administered intravenously every three weeks in combination with carboplatin and etoposide chemotherapy for first-line treatment.

A Randomized, Double-blind, Placebo Controlled Phase III Study to Investigate Efficacy and Safety of HLX10 + Chemotherapy (Carboplatin- Etoposide) in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC)

NCT04063163Unknown StatusPhase 3
Shanghai Henlius Biotech
Posted 9/12/2019

Sandoz Launches First Interchangeable Denosumab Biosimilars in US, Expanding Access for Osteoporosis and Cancer Patients

Monoclonal AntibodyDrug Approval
  • Sandoz has launched WYOST® and Jubbonti®, the first and only FDA-approved interchangeable denosumab biosimilars in the United States, providing cost-effective alternatives to reference medicines XGEVA® and Prolia®.
  • The biosimilars target over 10 million US adults with osteoporosis and approximately 330,000 patients living with bone metastases from cancer.
  • Both products are human monoclonal antibodies that bind to RANKL protein and are approved for all indications of their respective reference medicines with identical dosing regimens.
  • The launch represents a significant milestone in biosimilar accessibility, potentially reducing treatment costs for patients with bone-related conditions and cancer complications.

A Phase 3 Study to Compare Between CT-P41 and US-licensed Prolia in Postmenopausal Women With Osteoporosis

NCT04757376CompletedPhase 3
Celltrion
Posted 6/17/2021

InnoCare Presents Promising Clinical Data for Multiple Oncology Pipeline Candidates at Major Medical Conferences

Monoclonal Antibody
  • InnoCare presented clinical data for multiple oncology pipeline candidates at the 2025 ASCO Annual Meeting and EHA 2025 Congress, demonstrating significant therapeutic potential across various cancer types.
  • The BCL2 inhibitor mesutoclax (ICP-248) showed 100% overall response rates in both BTK-naïve chronic lymphocytic leukemia and mantle cell lymphoma patients, with combination therapy achieving 97.6% response rates in treatment-naïve patients.
  • The pan-TRK inhibitor zurletrectinib (ICP-723) demonstrated 100% confirmed response rates in pediatric patients with NTRK fusion-positive solid tumors and 83.7% response rates in adult patients.
  • The anti-CCR8 antibody ICP-B05 achieved 33.3% partial response rates in relapsed/refractory cutaneous T-cell lymphoma patients, with an 82.5% six-month progression-free survival rate.

Atezolizumab Plus Chemotherapy Reduces Recurrence Risk by 50% in Stage III dMMR Colon Cancer

Monoclonal AntibodyOncology
  • The phase 3 ATOMIC trial demonstrated that adding atezolizumab to standard chemotherapy reduced the risk of recurrence or death by 50% in patients with stage III dMMR colon cancer.
  • Three-year disease-free survival improved significantly from 76.6% with chemotherapy alone to 86.4% with the combination treatment across 712 patients.
  • This represents the first successful immunotherapy adjuvant study in colon cancer and establishes a new standard of care for this patient population.
  • The safety profile was manageable, with only a slight increase in nonfebrile neutropenia compared to known profiles of each individual treatment.

Randomized trial of standard chemotherapy alone or combined with atezolizumab as adjuvant therapy for patients with stage III colon cancer and deficient DNA mismatch repair (ATOMIC)

2024-517269-18-00Active, Not RecruitingPhase 3
National Cancer Institute, AIO-Studien gGmbH
Posted 10/16/2017

AstraZeneca Advances AZD0022, Novel Oral KRASG12D Inhibitor, in First-in-Human Phase I/IIa Trial

Monoclonal AntibodyTargeted TherapyOncology
  • AstraZeneca is developing AZD0022, a potent oral KRASG12D-selective inhibitor that demonstrates robust pathway inhibition and anti-tumor activity in preclinical models.
  • The drug is currently being investigated in the ALAFOSS-01 study, a first-in-human Phase I/IIa trial for patients with KRASG12D-mutated solid tumors.
  • Preclinical data shows enhanced therapeutic responses when AZD0022 is combined with cetuximab, with sustained tumor regressions observed in colorectal and pancreatic cancer models.
  • The clinical trial includes both monotherapy and combination therapy modules, targeting multiple cancer types including colorectal, lung, and pancreatic cancers.

A trial to learn how safe AZD0022 is, how well it works, and how it moves throughout the body over time in adults with tumors that have a KRAS-G12D mutation, when given alone and with other cancer drugs

2024-516699-14-00RecruitingPhase 1/2
AstraZeneca AB
Posted 10/18/2024

Dual Immunotherapy Combination Significantly Extends Survival in Advanced Cutaneous Squamous Cell Carcinoma

Monoclonal AntibodyOncology
  • A phase II clinical trial demonstrated that combining avelumab and cetuximab nearly quadrupled median progression-free survival compared to avelumab alone in patients with advanced cutaneous squamous cell carcinoma.
  • The combination therapy achieved a median progression-free survival of 11.1 months versus 3.0 months for avelumab monotherapy, with a hazard ratio of 0.48 and statistical significance.
  • The study enrolled 57 evaluable patients with advanced cSCC, showing that dual immunotherapy targeting both PD-L1 and EGFR pathways creates synergistic anti-tumor effects.
  • Results provide valuable insights for future trials combining standard-of-care immunotherapies with cetuximab to improve outcomes in this aggressive skin cancer.

Avelumab with or Without Cetuximab in Treating Patients with Advanced Skin Squamous Cell Cancer

NCT03944941Active, Not RecruitingPhase 2
Alliance for Clinical Trials in Oncology
Posted 6/17/2019

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