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NIHR Pilots 'Just in Time' Clinical Trial Initiative for Pancreatic Cancer Using Pembrolizumab-Olaparib Combination

Precision MedicineOncology
  • The National Institute for Health and Care Research is piloting a 'Just in Time' scheme that could reduce clinical trial setup time from months to days, potentially improving patient access to trials closer to home.
  • The initiative is being tested in the PemOla trial, which explores combination immunotherapy using pembrolizumab and olaparib for pancreatic cancers with high genetic mutation burden.
  • Pancreatic cancer remains one of the most challenging cancers to treat, with only 5% of patients surviving more than 10 years and limited progress in outcomes over the past 50 years.
  • The scheme enables hospitals to join trials when eligible patients are identified, potentially accelerating recruitment and speeding development of precision medicines for rare patient groups.

FDA-Approved Rectal Cancer Drug Metric Fails to Predict Long-Term Survival, Tulane Study Finds

Drug ApprovalOncology
  • A Tulane University meta-analysis of 25 clinical trials involving nearly 12,000 rectal cancer patients found no statistical relationship between pathologic complete response (pCR) and overall survival.
  • The study challenges the FDA's 2012 decision to allow pharmaceutical companies to use tumor-free status post-therapy as a surrogate for overall survival in drug approvals.
  • Researchers warn that cancer drugs may be fast-tracked for approval without demonstrating meaningful long-term improvements over existing treatments.
  • The findings suggest that relying solely on pCR as an endpoint may lead to increased costs for drug companies investing in therapies that cannot guarantee improved survival rates.

Rectal Cancer And Pre-operative Induction Therapy Followed by Dedicated Operation. The RAPIDO Trial

NCT01558921Active, Not RecruitingPhase 3
University Medical Center Groningen
Posted 6/21/2011

Moleculin Appoints Roche Veteran Adriano Treve as Strategic Advisor Ahead of Phase 3 AML Trial Data

Oncology
  • Moleculin Biotech has appointed Adriano Treve, a 40-year Roche veteran, as Strategic Advisor for partnerships as the company approaches key milestones in its Phase 3 MIRACLE trial.
  • The appointment comes ahead of the first unblinding of data for 45 patients in the Phase 2B/3 MIRACLE trial evaluating Annamycin in combination with cytarabine for relapsed or refractory acute myeloid leukemia.
  • Treve's extensive international experience and market access expertise are expected to enhance Moleculin's strategic positioning as interest from potential partners has significantly increased.
  • The company expects to reach the first unblinding in the second half of 2025, with the second unblinding anticipated in the first half of 2026.

Quetzal Therapeutics Launches with $50 Million to Advance Oral Arsenic Trioxide Therapy for Acute Promyelocytic Leukemia

Rare DiseaseOncology
  • Quetzal Therapeutics officially launched with $50 million in committed capital to develop transformative therapies for rare and life-threatening diseases.
  • The company's lead candidate QTX-2101 is a novel oral arsenic trioxide therapy for Acute Promyelocytic Leukemia expected to enter Phase III trials by late 2025.
  • QTX-2101 is supported by encouraging comparative pharmacokinetic data from a Phase 1b trial previously sponsored by Syros Pharmaceuticals.
  • The company is led by experienced pharmaceutical executives and guided by an accomplished board including oncology drug development experts.

Johnson & Johnson Raises 2025 Outlook as Oncology Portfolio Drives 24% Growth

CAR-TOncology
  • Johnson & Johnson reported strong Q2 2025 results with total sales of $23.7 billion, driven by 24% growth in oncology and 15.1% growth in neuroscience divisions.
  • The company raised its full-year 2025 sales guidance from $91-91.8 billion to $93.2-93.6 billion and set an ambitious target to grow oncology sales to $50 billion by 2030.
  • Multiple myeloma drug Darzalex led oncology growth with $3.54 billion in sales, while CAR-T therapy Carvykti generated $439 million and new bispecific antibodies contributed to portfolio expansion.
  • Despite strong performance in growth areas, Stelara sales declined 42.7% to $1.65 billion due to biosimilar competition, creating an 1,170 basis point impact on overall growth.

NCI Initiates $4.8 Million Clinical Trial of Senhwa's First-in-Class Cancer Drug CX-5461

Oncology
  • The U.S. National Cancer Institute has selected Senhwa Biosciences' Pidnarulex (CX-5461) for a five-year cancer research program, with the first patient enrolled in a monotherapy trial for advanced solid tumors.
  • The NCI will fully fund the clinical trial at approximately $4.8 million, investigating CX-5461's ability to induce DNA damage through G-quadruplex stabilization in patients with and without homologous recombination deficiency mutations.
  • Three additional NCI-sponsored studies are planned, including combination therapies with immunotherapy and antibody-drug conjugates, as well as a monotherapy study targeting MYC-driven lymphomas.
  • The global cancer immunotherapy market is projected to reach $224.3 billion by 2030, but current treatments benefit only 20-25% of patients, highlighting the need for novel combination approaches.

FDA Advisory Panel Votes Against GSK's Blenrep for Multiple Myeloma Over Eye Safety Concerns

Drug ApprovalOncology
  • FDA advisers voted that the risks of GSK's blood cancer drug Blenrep outweigh its benefits in treating multiple myeloma, citing serious eye-related side effects as a primary concern.
  • The drug causes ocular toxicity that represents "unique toxicity not seen with any currently available treatments for multiple myeloma," according to FDA staff reviewers.
  • FDA staff suggested that lower dosages of Blenrep could offer patients similar efficacy while reducing the risk of side effects, questioning the company's selected dose.
  • The FDA is expected to make its final approval decision by next week, though the agency does not have to follow the advisory panel's recommendation.

Evestia Clinical Merges with Atlantic Research Group to Create Global Specialist CRO

NeurologyOncology
  • Evestia Clinical (formerly EMAS Pharma) has merged with US-based Atlantic Research Group to create an independent global specialist CRO group in fast-growing markets.
  • The merger more than doubles Evestia Clinical's size by headcount and service delivery capability while expanding its US footprint and therapeutic offerings to include neurology and late-stage clinical trials.
  • The combined group will provide full clinical trial services from Phase 1 through Phase 3 and beyond, with enhanced technologies and specialized services across multiple therapeutic areas.
  • Following integration, the enlarged group will be headquartered in the UK (Letchworth) and USA (Charlottesville, VA) with global capabilities through its network of offices and expert partners.

Oncomatryx Secures €12.5 Million EIC Accelerator Funding to Advance Novel ADC Platform for Hard-to-Treat Cancers

Oncology
  • Oncomatryx Biopharma received €12.5 million in EIC Accelerator funding, comprising €2.5 million in grants and €10 million in equity investment, making it the only oncology company selected among 40 recipients from 959 applications.
  • The company's lead ADC candidate OMTX705 demonstrated outstanding safety with no dose-limiting toxicity and showed long responses in 95 patients with metastatic immune-cold solid tumors expressing FAP.
  • Funding will support expansion cohorts of ongoing Phase I trials in pancreatic, colorectal, and lung cancer, with randomized clinical trials currently underway for these indications.

UCLA Researchers Receive $950,000 Grant to Launch Multi-Institutional Trial of Zipalertinib for EGFR-Mutated Cancers

Targeted TherapyOncology
  • UCLA's Arjan Gower received a $950,000 grant from the National Comprehensive Cancer Network and Taiho Oncology Inc. to launch a multi-institutional clinical trial testing zipalertinib.
  • The investigational drug targets specific EGFR mutations, including Exon 20 insertions, which drive cancer growth and resist standard treatments.
  • This funding represents a significant investment in developing targeted therapies for previously difficult-to-treat EGFR-mutated cancers.
  • The multi-institutional approach suggests broad clinical collaboration to evaluate this novel targeted therapy's potential.

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