MedPath

Tagged News

Pfizer Receives CDSCO Approval for Phase 3 Trial of HER2-Targeting ADC Disitamab Vedotin

Oncology
• India's CDSCO expert panel has granted Pfizer conditional approval to conduct Phase 3 clinical trials of Disitamab Vedotin, an antibody-drug conjugate targeting HER2-positive solid tumors.
• The approval requires Pfizer to include more geographically distributed government sites across India and mandates that principal investigators must be medical oncologists.
• Disitamab Vedotin (RC48) combines a HER2-targeting monoclonal antibody with cytotoxic agent monomethyl auristatin E (MMAE), showing promise for gastric and urothelial cancers.

Onco-Dermatology Emerges as Critical Component of Multidisciplinary Cancer Care

Targeted TherapyOncology
  • Onco-dermatology has become essential for managing skin, hair, and nail toxicities from modern cancer therapies, with different treatment modalities causing distinct dermatologic adverse effects.
  • Multidisciplinary collaboration between oncologists, dermatologists, and pharmacists enables proactive management strategies that keep patients on life-saving cancer treatments while maintaining quality of life.
  • Recent advances include preemptive treatment protocols for EGFR inhibitor-induced rashes and scalp cooling technology for chemotherapy-induced hair loss, particularly benefiting breast cancer patients.
  • Evidence-based preventive strategies and early intervention protocols are being developed through ongoing clinical trials to optimize patient outcomes and treatment adherence.

EL1SSAR Trial Confirms Efficacy of Atezolizumab Plus Nab-Paclitaxel in PD-L1-Positive Advanced TNBC

OncologyMonoclonal Antibody
  • The phase IIIb EL1SSAR trial demonstrates that atezolizumab plus nab-paclitaxel provides significant clinical benefit in PD-L1-positive advanced triple-negative breast cancer, with median overall survival reaching 27 months in the overall population.
  • Patients with centrally confirmed PD-L1-positive tumors showed superior outcomes, with median progression-free survival of 11.1 months and overall survival not yet reached, highlighting the importance of accurate biomarker testing.
  • The safety profile was consistent with previous findings from the IMpassion130 trial, with 47% of patients experiencing grade ≥3 adverse events and 12% developing grade ≥2 immune-mediated adverse events, with no treatment-related deaths reported.

A Study of Atezolizumab Plus Nab-Paclitaxel in the Treatment of Unresectable Locally Advanced or Metastatic PD-L1-Positive Triple-Negative Breast Cancer

NCT04148911CompletedPhase 3
Hoffmann-La Roche
Posted 12/17/2019

Eisai's Remitoro Clears Post-Marketing Surveillance Requirements for T-Cell Lymphoma Treatment in Japan

OncologyRare DiseaseTargeted Therapy
  • Japan's Ministry of Health has lifted the all-case surveillance requirement for Eisai's anticancer agent Remitoro after reviewing safety data from 111 patients and efficacy data from 85 patients with T-cell lymphoma.
  • Remitoro, a fusion protein combining IL-2 and diphtheria toxin, demonstrated an overall response rate of 16.5% across both peripheral and cutaneous T-cell lymphoma patients in the post-marketing study.
  • Common adverse reactions included elevated liver enzymes (22.5%), capillary leak syndrome (21.6%), and decreased platelet count (15.3%), confirming the safety profile in real-world clinical settings.

AI in Oncology: Transforming Community Practice from Patient Care to Revenue Cycles

AIOncologyPrecision Medicine
  • AI adoption in oncology practices is rapidly growing, with current utilization at 40-50% and projected to reach 70-80% in the next few years, enhancing both clinical decision support and practice operations.
  • AI technologies are improving patient care by facilitating education, reducing financial toxicity, streamlining practice connections, and helping clinicians manage the increasing complexity of precision medicine data.
  • Community oncology practices need a pragmatic, strategic approach to AI implementation that prioritizes specific practice needs, workflow integration, and patient readiness to maximize benefits while addressing potential disparities.

FDA Advisory Committee Rejects UroGen's Bladder Cancer Therapy UGN-102

Oncology
  • UroGen Pharma's stock plummeted approximately 47% after an FDA advisory committee voted against its bladder cancer therapy UGN-102 (mitomycin), citing concerns over study design.
  • The FDA had repeatedly recommended a randomized trial design, noting that the Envision trial's lack of a concurrent control arm made primary endpoints difficult to interpret.
  • Despite UroGen reporting an 80.6% probability of patients remaining in complete response at 18 months, the regulatory setback highlights challenges in developing alternatives to surgical intervention for bladder cancer.

Landmark VA Study Reveals Genomic Differences in Metastatic Prostate Cancer Across Racial Groups

OncologyPrecision Medicine
  • Researchers from Moffitt Cancer Center and partners analyzed genomic data from over 5,000 veterans with metastatic prostate cancer, finding significant biological differences between non-Hispanic Black and white patients.
  • Non-Hispanic Black veterans showed higher rates of genomic alterations associated with immunotherapy benefit, while white veterans had more frequent mutations in DNA repair genes and androgen receptor pathways.
  • Despite these biological differences, both groups demonstrated similar survival outcomes when given equal access to care, highlighting the potential of precision oncology to reduce healthcare disparities.

Alvotech Expands European Presence with Successful Nasdaq Stockholm Listing

Oncology
  • Alvotech's Swedish Depository Receipts (SDRs) offering was multiple times oversubscribed, attracting over 3,000 new shareholders and raising approximately SEK 39 million.
  • The biosimilar developer's strategic expansion includes acquiring Xbrane's R&D operations at the Karolinska life-science hub, strengthening its research capabilities and establishing a footprint in Sweden's biotech sector.
  • Trading of Alvotech's SDRs on Nasdaq Stockholm commenced on May 19, 2025, under the ticker "ALVO SDB," enhancing the company's access to Nordic and European investors and capital markets.

Remedy Plan Therapeutics Secures $18 Million to Advance Novel NAMPT Inhibitor for AML and MDS Treatment

Oncology
• Gaithersburg-based Remedy Plan Therapeutics has raised $18 million in an oversubscribed insider financing round, bringing their total funding to $55 million to date.
• The funding will accelerate the development of RPT1G, their first-in-class NAMPT inhibitor, into Phase 1/2 clinical trials for acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (MDS).
• Remedy Plan's innovative "hyperbolic" approach to NAMPT inhibition avoids the on-target toxicities that have hindered previous development efforts, potentially addressing over 20 diseases spanning oncology, autoimmunity, and metabolic disorders.

A Study of RPT1G After Single and Multiple Doses in Healthy Adult Participants

NCT06667765Active, Not RecruitingPhase 1
Remedy Plan, Inc.
Posted 11/18/2024

Revolution Medicines Advances First-in-Class KRAS(G12D) Molecular Glue Inhibitor RMC-9805 with Novel Cyclophilin A Mechanism

OncologyTargeted Therapy
  • Revolution Medicines has developed RMC-9805, a first-in-class covalent KRAS(G12D)(ON) molecular glue inhibitor that targets the previously "undruggable" KRAS(G12D) mutant using a cyclophilin A-recruiting tricomplex mechanism.
  • The compound employs a finely tuned aziridine covalent handle to engage a poorly nucleophilic mutant Asp residue, representing a breakthrough in targeting this challenging oncogenic mutation.
  • Preclinical data presented at AACR 2024 demonstrated that RMC-9805 synergizes with PD-1 inhibitors, and the compound is making progress in clinical development.
  • The discovery leveraged structural and modeling insights to overcome the technical challenges of inhibiting KRAS(G12D), which has been considered one of the most difficult cancer targets to drug.

A Study of BMS-986449 With and Without Nivolumab in Participants With Advanced Solid Tumors

NCT05888831Active, Not RecruitingPhase 1
Bristol-Myers Squibb
Posted 6/6/2023

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.