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Samuraciclib Shows Promise in Advanced Breast Cancer Patients After CDK4/6 Inhibitor Failure

OncologyTargeted TherapyPrecision Medicine
  • Phase I clinical trials demonstrate samuraciclib, a selective CDK7 inhibitor, has an acceptable safety profile with manageable gastrointestinal side effects and shows clinical activity in various advanced solid tumors.
  • In HR+/HER2- breast cancer patients who progressed on CDK4/6 inhibitors, the combination of samuraciclib with fulvestrant achieved a clinical benefit rate of 36% and median progression-free survival of 3.7 months.
  • Exploratory analysis revealed patients without TP53 mutations had significantly longer progression-free survival (7.4 months vs 1.8 months), suggesting TP53 status may serve as a potential biomarker for treatment response.

Modular Study to Evaluate CT7001 Alone in Cancer Patients With Advanced Malignancies

NCT03363893CompletedPhase 1
Carrick Therapeutics Limited
Posted 11/14/2017

Avutometinib-Defactinib Combination Shows 45% Response Rate in Low-Grade Serous Ovarian Cancer

Targeted TherapyOncology
  • A phase II trial of avutometinib combined with defactinib demonstrated a 45% response rate in patients with advanced low-grade serous ovarian cancer, nearly twice as effective as current best treatments.
  • Patients with KRAS mutations showed particularly strong responses at 60%, while those without mutations still achieved a 29% response rate, both significantly higher than standard therapy response rates of 0-14%.
  • The dual RAF/MEK inhibitor combination proved over four times more effective than avutometinib alone, with previous phase I data showing an average progression-free survival of 23 months.
  • Low-grade serous ovarian cancer affects approximately 700 women annually in the UK and represents about 10% of all ovarian cancer cases, typically affecting younger women with poor response to conventional treatments.

Phase I Trial of Defactinib and VS-6766.

NCT03875820Active, Not RecruitingPhase 1
Institute of Cancer Research, United Kingdom
Posted 12/12/2017

Trametinib in Treating Patients With Recurrent or Progressive Low-Grade Ovarian Cancer or Peritoneal Cavity Cancer

NCT02101788Active, Not RecruitingPhase 2
National Cancer Institute (NCI)
Posted 2/27/2014

A Study of MEK162 vs. Physician's Choice Chemotherapy in Patients With Low-grade Serous Ovarian, Fallopian Tube or Peritoneal Cancer

NCT01849874TerminatedPhase 3
Pfizer
Posted 6/27/2013

A Study of Avutometinib (VS-6766) V. Avutometinib (VS-6766) + Defactinib in Recurrent Low-Grade Serous Ovarian Cancer with and Without a KRAS Mutation

NCT04625270Active, Not RecruitingPhase 2
Verastem, Inc.
Posted 12/21/2020

Vorasidenib Shows Promise as First Targeted Therapy for IDH-Mutant Low-Grade Gliomas

Targeted TherapyDrug ApprovalOncology
  • Vorasidenib, the first targeted therapy developed specifically for brain cancer, more than doubled progression-free survival in patients with recurrent grade 2 glioma carrying IDH1/IDH2 mutations, extending the time without disease progression from 11.1 months to 27.7 months.
  • The international INDIGO trial involving 331 patients demonstrated that vorasidenib delayed the need for chemotherapy and radiation by nearly 17 months compared to placebo, with 85.6% of patients going 18 months before requiring next treatment.
  • The drug showed excellent tolerability with limited adverse effects, offering a new treatment option for younger patients typically in their 30s and 40s who face cognitive deficits from standard radiation and chemotherapy treatments.
  • Results from this phase 3 study, published in the New England Journal of Medicine and presented at ASCO, are expected to establish a new standard of care for IDH-mutant low-grade gliomas pending FDA approval.

FDA Approves Two Bispecific T-Cell Engagers for Relapsed/Refractory B-Cell Lymphomas

Drug ApprovalOncology
  • The FDA has granted accelerated approval to epcoritamab-bysp (Epkinly), the first T-cell engaging bispecific antibody for relapsed/refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy.
  • Epcoritamab demonstrated a 61% overall response rate with a 38% complete response rate in the EPCORE NHL-1 trial, with a median duration of response of 15.6 months.
  • The FDA also approved glofitamab-gxbm (Columvi), another CD20/CD3-targeted bispecific T-cell engager, showing a 56% overall response rate and 43% complete response rate in clinical trials.
  • Both therapies carry boxed warnings for serious immune-related adverse reactions including cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome.

First-in-Human (FIH) Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma

NCT03625037Active, Not RecruitingPhase 1
Genmab
Posted 6/26/2018

Revumenib Shows Promise in Phase 1 Trial for KMT2A-Rearranged and NPM1-Mutated Acute Leukemia

OncologyTargeted Therapy
  • Revumenib, a first-in-class menin inhibitor, demonstrated a 30% complete remission rate in heavily pretreated patients with KMT2A-rearranged or NPM1-mutated acute leukemia, with 78% achieving undetectable measurable residual disease.
  • The oral therapy works by disrupting the menin-KMT2A interaction, downregulating key leukemogenic genes and promoting differentiation of leukemic cells, addressing a critical unmet need for these poor-prognosis genetic subtypes.
  • While QT interval prolongation was the most common treatment-related adverse event (53%), the phase 1 trial established recommended phase 2 dosing with manageable safety profile, supporting further development of this targeted therapy.

BriaCell Advances Pivotal Study for Bria-IMT in Metastatic Breast Cancer Following Positive FDA Feedback

Oncology
  • BriaCell Therapeutics has received positive FDA feedback for its pivotal study of Bria-IMT in combination with a checkpoint inhibitor for advanced metastatic breast cancer, potentially accelerating commercialization.
  • The FDA has agreed on the eligible patient population—breast cancer patients who have failed available approved therapies—and the primary endpoint of survival improvement compared to physician's choice of treatment.
  • BriaCell is also preparing to launch its Bria-OTS personalized treatment program, which matches patients' HLA type with pre-manufactured cells, with dosing expected to begin in the first half of 2023.

BDR Pharmaceutical Launches First Generic Apalutamide in India for Prostate Cancer Treatment

Oncology
  • BDR Pharmaceutical has launched India's first generic version of apalutamide (brand name Apatide) for treating metastatic castration-sensitive and non-metastatic castration-resistant prostate cancer.
  • The generic drug is priced at one-third the cost of the innovator brand, with 60 tablets costing Rs 22,500 and 120 tablets costing Rs 45,000.
  • Clinical data from the SPARTAN trial showed apalutamide plus androgen-deprivation therapy reduced disease progression risk by 71% and improved median progression-free survival from 14.7 to 40.5 months.
  • The launch addresses India's growing prostate cancer burden, where it ranks as the second most common cancer and sixth leading cause of cancer deaths among men.

Roche Withdraws Tecentriq from Bladder Cancer Market Following Failed Confirmatory Trial

Oncology
  • Roche voluntarily withdrew Tecentriq (atezolizumab) from the U.S. bladder cancer market after the IMVigor130 trial failed to demonstrate statistically significant overall survival benefit.
  • The phase 3 confirmatory trial showed patients receiving Tecentriq plus chemotherapy lived a median of 16 months compared to 13.4 months with chemotherapy alone, but the difference was not statistically significant.
  • This withdrawal completes the removal of all "dangling" accelerated approvals for Tecentriq, reflecting increased FDA scrutiny of cancer immunotherapy approvals that failed confirmatory studies.
  • The decision affects treatment for locally advanced or metastatic urothelial carcinoma patients who are cisplatin-ineligible, leaving a significant unmet medical need in advanced bladder cancer.

Study of Atezolizumab as Monotherapy and in Combination With Platinum-Based Chemotherapy in Participants With Untreated Locally Advanced or Metastatic Urothelial Carcinoma

NCT02807636CompletedPhase 3
Hoffmann-La Roche
Posted 6/30/2016

A Study of Atezolizumab in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer (Cohort 2)

NCT02108652CompletedPhase 2
Hoffmann-La Roche
Posted 5/31/2014

Genmab and AbbVie Submit Regulatory Applications for Epcoritamab Bispecific Antibody in Relapsed/Refractory B-Cell Lymphomas

Oncology
  • Genmab submitted a Biologics License Application to the FDA for subcutaneous epcoritamab to treat relapsed/refractory large B-cell lymphoma after two or more lines of systemic therapy.
  • AbbVie's Marketing Authorization Application for epcoritamab in relapsed/refractory diffuse large B-cell lymphoma has been validated by the European Medicines Agency.
  • The regulatory submissions are supported by results from the pivotal EPCORE NHL-1 Phase 2 trial evaluating epcoritamab's safety and efficacy in patients with CD20+ mature B-cell non-Hodgkin lymphoma.
  • Epcoritamab is an investigational bispecific antibody designed to simultaneously bind CD3 on T-cells and CD20 on B-cells, inducing T-cell mediated killing of malignant B-cells.

Photocure and Karl Storz Launch Advanced Blue Light Cystoscopy System in US Market

Oncology
  • Photocure ASA announces the commercial availability of Karl Storz's New Blue Light equipment powered by Saphira technology in the United States for bladder cancer detection.
  • The advanced system shows strong market demand with orders outpacing previous systems, signaling potential for blue light cystoscopy to become standard of care for bladder cancer visualization.
  • Bladder cancer affects 1.72 million patients globally with high recurrence rates up to 78% over five years, making improved detection technology critically important for patient outcomes.

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