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Replimune's RP1 Melanoma Therapy Nears FDA Decision with July PDUFA Date as Commercial Infrastructure Readies for Launch

Oncology
• Replimune's BLA for RP1 (vusolimogene oderparepvec) plus nivolumab in advanced melanoma is proceeding on schedule with a PDUFA date of July 22, 2025, following completed manufacturing inspections and late cycle review.
• The company has fully established its commercial infrastructure ahead of potential launch, targeting approximately 13,000 annual U.S. patients who progress on PD-1 treatment, with an estimated 80% eligible for RP1 therapy.
• Replimune maintains a strong financial position with $483.8 million in cash, cash equivalents and short-term investments as of March 31, 2025, providing runway into Q4 2026 to support commercialization efforts.

UCLA Study Reveals SSRIs May Enhance Immune Response Against Cancer

Oncology
  • UCLA researchers discovered that selective serotonin reuptake inhibitors (SSRIs) can enhance T cells' ability to fight cancer, reducing tumor size by more than half in multiple cancer models.
  • The study, published in Cell, demonstrated SSRIs' effectiveness against melanoma, breast, prostate, colon, and bladder cancers in both mouse and human tumor models.
  • Combining SSRIs with existing cancer immunotherapies showed promising results, suggesting potential for repurposing these widely used antidepressants as cancer treatments.

Elicera's iTANK-Armed CAR T-Cell Therapy Shows Complete Response in Lymphoma Patients

CAR-TOncology
  • Elicera Therapeutics reports that two out of three patients in the first cohort of the CARMA study achieved complete metabolic response with ELC-301, an iTANK-armed CD20-targeting CAR T-cell therapy.
  • The promising results were achieved despite using only one-tenth of the planned maximum dose in a challenging patient population, including one patient who had previously failed standard CD19 CAR T-cell therapy.
  • The Phase I/IIa CARMA study has already progressed to its second cohort, where patients are receiving a dose three times higher than the initial cohort, with further data expected as the trial advances.

Dual mTORC1/2 Inhibitor BI 860585 Shows Promise in Phase I Breast Cancer Trial

Oncology
  • A Phase I study of BI 860585, a novel dual mTORC1/2 inhibitor, demonstrated manageable safety profile and preliminary efficacy in advanced breast cancer patients.
  • The trial evaluated BI 860585 both as monotherapy and in combination with exemestane or paclitaxel, showing potential for overcoming resistance mechanisms in hormone receptor-positive breast cancer.
  • Researchers observed dose-dependent target inhibition and disease stabilization in several patients, supporting further investigation in larger clinical trials.

BI 860585 Dose Escalation Single Agent and in Combination With Exemestane or With Paclitaxel in Patients With Various Advanced and/or Metastatic Solid Tumors

NCT01938846CompletedPhase 1
Boehringer Ingelheim
Posted 9/5/2013

Surgeons Complete World's First Human Bladder Transplant in Groundbreaking Procedure

Oncology
  • Surgeons from USC and UCLA successfully performed the world's first human bladder transplant on May 4, 2025, marking a historic milestone in transplant medicine.
  • The 41-year-old patient, who had lost most of his bladder to cancer treatment and suffered kidney failure, received both a new bladder and kidney in an eight-hour procedure.
  • Post-transplant results exceeded expectations, with immediate kidney function restoration and the patient regaining natural urination ability after seven years.
  • The breakthrough offers new hope for patients with terminal bladder conditions, though experts caution about lifelong immunosuppression requirements and potential complications.

NUS Researchers Develop NExT: A Revolutionary Gene Delivery Platform for Cancer Immunotherapy

CAR-TOncology
  • Researchers at the National University of Singapore have developed Nanostraw Electro-actuated Transfection (NExT), a non-viral technology that efficiently delivers genetic material into immune cells with minimal disruption.
  • The NExT platform can transfect over 14 million immune cells in a single run with up to 94% efficiency for proteins and 80% for mRNA, while maintaining essential tumor-fighting characteristics.
  • This breakthrough could significantly reduce manufacturing costs and improve accessibility of CAR-T cell therapies, which currently cost approximately S$670,000 per infusion in Singapore.

Pharmacists Take Central Role in Managing Novel Cancer Therapies as CAR-T and Bispecific Antibodies Transform Treatment Landscape

CAR-TOncology
  • Pharmacists have evolved from traditional dispensing roles to comprehensive patient management in cancer care, particularly with novel therapies like CAR-T cell therapy and bispecific antibodies.
  • Patient selection has become a critical pharmacist responsibility, as not every patient qualifies for these advanced therapies and multiple treatment options require careful evaluation.
  • Pharmacists now proactively manage toxicities by monitoring lab results and patient symptoms, enabling dose adjustments and prophylactic interventions to maintain treatment continuity.
  • The expanded role includes value-based care participation, medication adherence monitoring, and close collaboration with multidisciplinary teams to optimize patient outcomes.

FDA Clears Avenzo Therapeutics' IND for AVZO-023, a Novel CDK4 Selective Inhibitor for Advanced Breast Cancer

Oncology
  • Avenzo Therapeutics has received FDA clearance for its investigational new drug application for AVZO-023, a highly selective CDK4 inhibitor with potential best-in-class properties for treating HR+/HER2- breast cancer.
  • The company plans to initiate a Phase 1/2 clinical trial in Q3 2025, evaluating AVZO-023 as monotherapy and in combination with endocrine therapy and their CDK2 inhibitor AVZO-021.
  • Preclinical data presented at AACR 2025 demonstrated AVZO-023's sub-nanomolar potency against CDK4 with high selectivity over CDK6, potentially reducing hematologic toxicity common with current CDK inhibitors.

New AI Blood Test ARTEMIS-DELFI Shows Promise for Monitoring Pancreatic Cancer Treatment Response

AIOncology
  • Johns Hopkins researchers have developed ARTEMIS-DELFI, an AI-powered blood test that detects tumor DNA fragments to monitor pancreatic cancer treatment response more effectively than traditional imaging methods.
  • The new technique outperformed conventional methods in two clinical trials, identifying patient responses as early as four weeks after treatment initiation, potentially allowing for faster therapy adjustments.
  • ARTEMIS-DELFI offers significant advantages over other approaches as it doesn't require tumor samples, works with more patients, and provides a simpler, potentially less expensive monitoring solution for pancreatic cancer patients.

Study of Nab-Paclitaxel and Gemcitabine With or Without Tocilizumab in Pancreatic Cancer Patients

NCT02767557CompletedPhase 2
Herlev Hospital
Posted 1/26/2017

Immune Checkpoint Inhibition in Combination With Radiation Therapy in Pancreatic Cancer or Biliary Tract Cancer Patients

NCT02866383CompletedPhase 2
Herlev Hospital
Posted 11/1/2016

Childhood Cancer Survivors Face Five-Fold Higher Risk of Kidney Disease and Hypertension

Oncology
  • A large population-based study of 10,182 childhood cancer survivors found they face a five-fold higher risk of developing chronic kidney disease and hypertension compared to the general pediatric population.
  • The elevated risk emerges as early as the first year after completing cancer treatment and persists throughout long-term follow-up, with cumulative incidence reaching 20.85% in survivors versus 8.05% in controls.
  • Current international surveillance guidelines lack specific recommendations for kidney monitoring in childhood cancer survivors, highlighting an urgent need for evidence-based screening protocols.
  • The findings support treating childhood cancer survivors as a high cardiovascular disease risk group requiring primary and secondary prevention strategies throughout their lifetime.

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