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Real-World Analysis Reveals Unexpected Safety Signals for Temozolomide in Glioma Treatment

Real World EvidenceOncology
  • A comprehensive analysis of 13,608 temozolomide-related adverse events from the FDA's FAERS database identified both expected hematologic toxicities and unexpected safety signals including pulmonary embolism and opportunistic infections.
  • The study found that blood and lymphatic system disorders showed the strongest safety signal with a relative odds ratio of 5.94, confirming temozolomide's known myelosuppressive effects in real-world settings.
  • Unexpected adverse events such as pulmonary embolism (ROR 4.96) and Pneumocystis jirovecii pneumonia (ROR 7.09) emerged as significant safety concerns, suggesting the need for updated clinical monitoring guidelines.
  • The findings support lowering thresholds for thromboprophylaxis and Pneumocystis prophylaxis in temozolomide-treated patients compared to current clinical guidelines.

GSK Advances Dostarlimab in Phase 3 Colon Cancer Trial and Phase 2 Endometrial Cancer Study

Oncology
  • GSK is conducting a Phase 3 randomized trial evaluating perioperative dostarlimab monotherapy versus standard of care in patients with untreated T4N0 or Stage III dMMR/MSI-H resectable colon cancer.
  • The colon cancer study, which began in August 2023, compares dostarlimab administered pre and post-surgery against standard treatments FOLFOX or CAPEOX.
  • A separate Phase 2 trial is testing dostarlimab combined with carboplatin-paclitaxel in Japanese patients with primary advanced or recurrent endometrial cancer.
  • Both studies represent significant opportunities for GSK to expand dostarlimab's therapeutic applications in oncology beyond its current indications.

BioNTech Chief Strategy Officer Ryan Richardson to Step Down After Seven-Year Tenure

OncologyCAR-T
  • Ryan Richardson will step down as Chief Strategy Officer from BioNTech's Management Board on September 30, 2025, after serving since January 2020.
  • Richardson played a pivotal role in BioNTech's transformation from a private clinical-stage biotech to a publicly listed company, contributing to over $1 billion in capital raising through IPO and subsequent financings.
  • The departure comes as BioNTech positions itself to become a multi-product company focused on cancer therapeutics, with the transition of Richardson's responsibilities already underway.
  • BioNTech's stock has shown resilience with a 13.9% quarterly increase and 30.09% annual return, outperforming the broader biotechnology sector despite ongoing challenges.

Telomir-1 Outperforms Standard Chemotherapy in Reversing Cancer Gene Silencing

Oncology
  • Telomir Pharmaceuticals' Telomir-1 fully reversed STAT1 gene silencing in aggressive prostate cancer cells, while Paclitaxel showed no effect and Rapamycin achieved only partial reduction.
  • The drug demonstrated unique ability to simultaneously reactivate both STAT1 and TMS1 tumor suppressor genes, potentially overcoming immune evasion and apoptosis resistance in cancer.
  • Telomir-1 did not elongate telomeres in cancer cells, reinforcing its safety profile and selective action in targeting appropriate cellular mechanisms.
  • Previous studies showed Telomir-1 reduced tumor volume by approximately 50% and eliminated chemotherapy-induced mortality when combined with Paclitaxel.

Belzutifan Demonstrates Superior Quality-Adjusted Survival Time Compared to Everolimus in Advanced Renal Cell Carcinoma

OncologyTargeted Therapy
  • Belzutifan showed a clinically meaningful 2.66-month improvement in quality-adjusted time without symptoms or toxicity (Q-TWiST) compared to everolimus in advanced renal cell carcinoma patients.
  • The phase 3 LITESPARK-005 trial demonstrated an 11.32% relative gain in Q-TWiST with belzutifan, despite numerically longer time with grade 3/4 toxicity.
  • Belzutifan patients experienced significantly longer time without symptoms and progression (10.73 vs 6.07 months) driven by prolonged periods without disease progression.
  • The analysis supports belzutifan's clinical benefit profile, with lead investigator Thomas Powles noting superior response rates, progression-free survival, and quality of life outcomes.

A Study of Belzutifan (MK-6482) Versus Everolimus in Participants With Advanced Renal Cell Carcinoma (MK-6482-005)

NCT04195750Active, Not RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 2/27/2020

Processa Pharmaceuticals Advances PCS6422 in Phase 2 Breast Cancer Trial with $7 Million Funding Boost

Oncology
  • Processa Pharmaceuticals is developing PCS6422, a lead oncology asset currently in Phase 2 clinical trials for breast cancer treatment.
  • The company focuses on transforming chemotherapy agents into more effective cancer therapies while minimizing toxicity to patients.
  • Processa recently secured $7 million in funding to support its innovative approach to oncology drug development.
  • CEO George Ng will discuss the company's progress and corporate developments on Bloomberg TV's Small Stocks, Big Money show.

Hengrui Medicine Advances Cancer Pipeline with Breakthrough Therapy Designations and Clinical Trial Approvals

Orphan DrugOncologyMonoclonal Antibody
  • Jiangsu Hengrui Medicine secured inclusion of two products on China's proposed breakthrough therapy list, highlighting their potential to address unmet medical needs in gastric cancer treatment.
  • The company received US FDA orphan drug designation for trastuzumab for injection, providing development incentives including tax credits and market exclusivity for this gastric cancer therapy.
  • Hengrui obtained clinical trial approval for three oncology drugs, enabling advancement of its cancer treatment research and potential commercialization of innovative therapies.
  • The pharmaceutical company partnered with GlaxoSmithKline to develop up to 12 innovative medicines across respiratory, immunology, inflammation, and oncology therapeutic areas.

Trogenix Strengthens Leadership Team with Key Clinical Appointments as Odysseus Platform Advances Toward Clinical Trials

Oncology
  • Trogenix has appointed Atif Abbas, MD as Chief Medical Officer, bringing over 25 years of oncology drug development experience including successful IND submissions for immunotherapy compounds and regulatory approvals.
  • Carolyn Edwards, PhD joins as Vice President of R&D with over 15 years of drug development expertise, focusing on accelerating the company's immuno-oncology pipeline.
  • The appointments come as Trogenix prepares to advance its Odysseus platform into clinical trials, with the lead asset showing curative potential in preclinical glioblastoma studies.
  • The Odysseus platform utilizes AAV vectors and proprietary Synthetic Super-Enhancers to deliver a "Trojan horse" approach for potentially curative one-and-done treatments for aggressive cancers.

Immunotherapy Combinations Transform Advanced Squamous Cell Anal Cancer Treatment Landscape

Oncology
  • The PODIUM-303 study establishes carboplatin/paclitaxel plus retifanlimab as emerging standard of care for advanced squamous cell anal cancer with compelling improvements in progression-free survival and response rates.
  • Checkpoint inhibitor interchangeability remains complex, with literature examples showing that swapping immunotherapy agents does not necessarily maintain efficacy, requiring clinicians to adhere to studied regimens.
  • Combination therapy provides both immediate cytotoxic effect and potentially durable immunotherapy response, addressing symptom control and long-term disease management for patients with advanced disease.
  • The ongoing E2176 study with nivolumab may provide additional comparative data with different design elements including 2:1 randomization and no crossover allowance.

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.

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