Rated R

AB Science announces that Health Canada has issued a Notice of Non-Compliance-Withdrawal (NON/w) for masitinib in ALS

Retrieved on: 
Lunedì, Febbraio 26, 2024
Bias, PFS, EMA, Function, ALS, Health Canada, ANCOVA, Progression-free survival, JTR, OS, Observation, Tracheotomy, Patient, Clinical trial, CIR, Drug, Science, CAFS, Rated R, Pharmaceutical industry

Health Canada stated that a Request for Reconsideration can be filed within 30 days of receiving the NON/w.

Key Points: 
  • Health Canada stated that a Request for Reconsideration can be filed within 30 days of receiving the NON/w.
  • The reconsideration process will re-examine, with new assessors, the decision based on information that was included in the original submission.
  • AB Science provided a methodologically justified new claim “patients with ALS prior to any loss of function”, where CAFS and Overall Survival (OS) are significantly improved.
  • Based on the supporting arguments and counterarguments outlined above, AB Science intends to submit a Request for Reconsideration.

Gamida Cell Data Presented at the 2024 Tandem Meetings of ASTCT® and CIBMTR®

Retrieved on: 
Venerdì, Febbraio 23, 2024
Tandem, Therapy, Infection, MD, TCT, FDA, Bone marrow, Cell, Health, Hematology, Society, Duke Cancer Institute, Science, White, Non-Hodgkin lymphoma, Patient, Fungal infection, NK, NAM, Rated R, Transplant, Rituximab, Cytokine release syndrome, EAP, Lymphoma, Pharmaceutical industry

BOSTON, Feb. 23, 2024 (GLOBE NEWSWIRE) -- Gamida Cell Ltd. (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today presented data highlighting its expanded access program (EAP) for FDA-approved allogeneic stem cell therapy Omisirge® (omidubicel-onlv) and Phase 1 data for its allogeneic cryopreserved natural killer (NK) cell therapy candidate GDA-201 at the 2024 Tandem Meetings, Transplantation & Cellular Therapy (TCT) Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood and Marrow Transplant Research (CIBMTR). The hybrid meetings take place February 21-24 virtually and in person in San Antonio, Texas.

Key Points: 
  • The hybrid meetings take place February 21-24 virtually and in person in San Antonio, Texas.
  • “The data presented at Tandem provide further evidence of the potential of Gamida Cell’s nicotinamide (NAM) technology to develop potentially curative therapies by expanding and enhancing cells,” said Ronit Simantov, MD, Chief Medical and Scientific Officer of Gamida Cell.
  • It allowed for institutional variability in conditioning regimens and supportive care, more closely reflecting the real-world environment.
  • Patients were heavily pretreated with a median of six prior lines of therapy including CAR-T cell therapy and hematopoietic stem cell transplant.

G1 Therapeutics to Continue Pivotal Phase 3 Trial of Trilaciclib in Metastatic Triple Negative Breast Cancer Following Interim Analysis by Independent Data Monitoring Committee

Retrieved on: 
Lunedì, Febbraio 12, 2024
G1 Therapeutics, Carboplatin, Breast cancer, Bone marrow, Data monitoring committee, DMC, OS, Safety, Therapy, TNBC, Patient, Survival, ITT, Rated R, Pharmaceutical industry

The DMC did not express any concerns regarding safety or recommend any other changes to the study.

Key Points: 
  • The DMC did not express any concerns regarding safety or recommend any other changes to the study.
  • G1 remains blinded to all data as the early stopping criteria were not met during the interim analysis.
  • PRESERVE 2 is a global, multi-center, randomized placebo-controlled, line extension pivotal Phase 3 trial of trilaciclib in patients with locally advanced unresectable or metastatic TNBC.
  • Patients meeting eligibility requirements were randomized 1:1 to receive either trilaciclib or placebo administered prior to first-line gemcitabine and carboplatin (GCb).

Korea University Researchers Unveil Benefits of Perioperative Radiotherapy for Treating Liver Cancer with High Recurrence Risk

Retrieved on: 
Mercoledì, Febbraio 7, 2024
OS, Radiation therapy, Rated R, Hepatocellular carcinoma, Survival, Meta-analysis, Patient, HCC, Recurrence, Canadian International Council, Radiation, Disease, Risk, DFS, Neoplasm, Cancer, Liver cancer, Liver, Survival rate, Korea University, Pharmaceutical industry

SEOUL, South Korea, Feb. 7, 2024 /PRNewswire/ -- More than two-thirds of patients with hepatocellular carcinoma (HCC), who receive surgical interventions, experience recurrence owing to lack of an established perioperative treatment. Now, researchers from Korea University have performed a meta-analysis to examine the oncological benefits of administering radiotherapy before or after surgery. The findings suggest that perioperative radiotherapy decreases the chances of recurrence in patients, improving their survival rate.

Key Points: 
  • Researchers have found that radiotherapy during liver cancer surgery reduces chances of recurrence and boosts survival for high-risk patients.
  • Now, researchers from Korea University have performed a meta-analysis to examine the oncological benefits of administering radiotherapy before or after surgery.
  • The findings suggest that perioperative radiotherapy decreases the chances of recurrence in patients, improving their survival rate.
  • This emphasizes the need for an adjuvant treatment like radiotherapy along with surgery for treating HCC patients with a high risk of recurrence.

ImmunityBio Quality-of-Life Study in BCG-Unresponsive Bladder Cancer Trial Indicates Improved Physical Function in the 71% Complete Responders Suggesting a Favorable Risk-Benefit Ratio for N-803 Plus BCG

Retrieved on: 
Lunedì, Febbraio 5, 2024
Oncology, Health, Infectious Diseases, Clinical Trials, Pharmaceutical, Biotechnology, Gemcitabine, Quality of life, Rated R, Docetaxel, NAI, NMIBC, Patient, Safety, CIS, UCLA, DSS, Pros, PRO, Incidence, Progression-free survival, Cancer, Diagnosis, FDA, SOC, Medicine, Cystectomy, Global health, Experiment (probability theory), DFS, Pembrolizumab, Carcinoma in situ, PDUFA, Associate, Bladder cancer, BCG, BLA, Bacillus

Overall, participants who achieved a complete response with the novel combination therapy reported better physical function by month six of the study than those who did not achieve a complete response.

Key Points: 
  • Overall, participants who achieved a complete response with the novel combination therapy reported better physical function by month six of the study than those who did not achieve a complete response.
  • “Many current therapies for bladder cancer slow disease progression but can cause debilitating side effects,” said Principal Investigator Karim Chamie, M.D., Associate Professor of Urology at UCLA.
  • Bladder cancer is the 10th most-commonly diagnosed cancer, with approximately 80% of newly diagnosed cases being NMIBC.
  • Safety and efficacy have not been established by any Health Authority or Agency, including the FDA.

Gamida Cell to Present at the 2024 Tandem Meetings of ASTCT® and CIBMTR®

Retrieved on: 
Mercoledì, Gennaio 17, 2024
NK, Patient, Infection, Transplant, Hematology, Safety, Rituximab, Society, Bone marrow, Cytokine release syndrome, Lymphoma, TCT, EAP, FDA, Therapy, Rated R, Cell

The hybrid meetings will take place virtually and in person at the Henry B. González Convention Center in San Antonio, Texas, February 21-24.

Key Points: 
  • The hybrid meetings will take place virtually and in person at the Henry B. González Convention Center in San Antonio, Texas, February 21-24.
  • Eligible patients ≥12 years of age received myeloablative conditioning, prophylactic medications and supportive care per individual institutional standards.
  • Omidubicel was approved under the brand name Omisirge® (omidubicel-onlv) by the U.S. FDA in April 2023 for allogeneic stem cell transplant.
  • There were no reported cases of immune effector cell associated neurotoxicity syndrome or graft versus host disease.

Merck’s KEYTRUDA® (pembrolizumab) Reduced the Risk of Death by 38% Versus Placebo as Adjuvant Therapy for Patients With Renal Cell Carcinoma (RCC) at an Increased Risk of Recurrence Following Nephrectomy

Retrieved on: 
Sabato, Gennaio 27, 2024
Research, FDA, Clinical Trials, Biotechnology, General Health, Pharmaceutical, Health, Science, Oncology, Other Science, MSD, Dana–Farber Cancer Institute, Renal cell carcinoma, Death, VEGF, Patient, M1, OS, RCC, Harvard Medical School, ASCO, Survival, DFS, Medicine, Society, NED, Cancer, Nephrectomy, Kidney, Risk, Recurrence, Disease, Safety, Eisai, Merck & Co., CPS, Rated R, MRK, Pharmaceutical industry

At 48 months, the estimated OS rate was 91.2% for patients who received KEYTRUDA compared to 86.0% for patients who received placebo.

Key Points: 
  • At 48 months, the estimated OS rate was 91.2% for patients who received KEYTRUDA compared to 86.0% for patients who received placebo.
  • Treatment-related adverse events (TRAEs) occurred in 79.1% of patients (n=386) in the KEYTRUDA arm and 53.0% of patients (n=263) in the placebo arm.
  • Grade 3-4 TRAEs occurred in 18.6% of patients in the KEYTRUDA arm and 1.2% of patients in the placebo arm.
  • Treatment-related adverse events resulting in discontinuation of any treatment occurred in 18.2% of patients in the KEYTRUDA arm and 0.8% of patients in the placebo arm.

Merck’s KEYTRUDA® (pembrolizumab) Significantly Improved Disease-Free Survival (DFS) as Adjuvant Therapy Versus Observation in High-Risk Patients With Localized Muscle-Invasive and Locally Advanced Urothelial Carcinoma After Surgery

Retrieved on: 
Venerdì, Gennaio 26, 2024
Biotechnology, FDA, Diabetes, Health, General Health, Pharmaceutical, Oncology, Other Science, Research, Science, Clinical Trials, MSD, Development, Death, Patient, OS, Carcinoma, Bladder cancer, ASCO, DFS, Society, NCI, Cancer, ClinicalTrials.gov, Risk, PD-L1, Recurrence, Disease, National Cancer Institute, Safety, Merck & Co., Observation, Pembrolizumab, Rated R, Bangladesh Technical Education Board, MRK, Pharmaceutical industry

Median DFS was 29.0 months (95% CI, 21.8-not evaluable [NE]) for KEYTRUDA and 14.0 months (95% CI, 9.7-20.20) for observation, an improvement of 15 months.

Key Points: 
  • Median DFS was 29.0 months (95% CI, 21.8-not evaluable [NE]) for KEYTRUDA and 14.0 months (95% CI, 9.7-20.20) for observation, an improvement of 15 months.
  • AMBASSADOR (A031501)/KEYNOTE-123 is a randomized, open-label Phase 3 trial (ClinicalTrials.gov, NCT03244384 ) evaluating KEYTRUDA versus observation for the adjuvant treatment of patients with localized MIUC and locally advanced resectable urothelial carcinoma.
  • 17.4% of patients receiving KEYTRUDA withdrew from the trial without event versus 27.2% from the observation arm.
  • Grade ≥3 adverse events occurred in 48.4% of patients receiving KEYTRUDA versus 31.8% of patients under observation.

Botensilimab/Balstilimab Breakthrough Data Presented at ASCO-GI Shows Unprecedented Tumor Shrinkage and Robust Biomarker Response in Prevalent Colorectal Cancer Population

Retrieved on: 
Lunedì, Gennaio 22, 2024
Oncology, Health, Infectious Diseases, Research, Science, Biotechnology, Patient, Neoplasm, Microsatellite, MSS, MSI-H, IST, DFS, BAL, Delays, Pathologic, Observational study, Rated R, Colorectal cancer, CRC, Diagnosis, BOT, Inc., Medical imaging

Dr. Pashtoon Kasi, M.D., Director of Colon Cancer Research at Weill-Cornell Medicine, presented these findings at the ASCO-GI conference.

Key Points: 
  • Dr. Pashtoon Kasi, M.D., Director of Colon Cancer Research at Weill-Cornell Medicine, presented these findings at the ASCO-GI conference.
  • "BOT/BAL's potential impact on colorectal cancer is groundbreaking.
  • BOT/BAL Eliminates Circulating Tumor DNA (ctDNA): patients in the NICHE-1 study were tested for ctDNA, a biomarker closely associated with long-term Disease-Free Survival (DFS).
  • Neoadjuvant BOT/BAL in both MSS and MSI-H CRC resulted in marked tumor regression and robust immune cell infiltration in a very short interval.

NEW PROSTATE CANCER FOUNDATION-FUNDED RESEARCH TO SPEED UP PROSTATE CANCER CLINICAL TRIALS WORLDWIDE

Retrieved on: 
Giovedì, Gennaio 11, 2024
Prostate Cancer Foundation, UCL, University College London, Prostate cancer, Patient, Progression-free survival, Research, Prostate Cancer UK, Rated R, Survival, Metastasis, Duke University, Division, Food, Journal, Disease, Doctor of Philosophy, PMID, Clinical trial, Pharmaceutical industry

LOS ANGELES, Jan. 11, 2024 /PRNewswire/ -- New analysis of data published by Susan Halabi, PhD, of Duke University could facilitate approval of new prostate cancer treatments almost two years earlier than the current standard.

Key Points: 
  • The study published online January 5, 2024, in the Journal of Clinical Oncology , reviewed data from over 8,500 men in nine different clinical trials.
  • Dr. Halabi said, "Prostate cancer readout in men with metastatic prostate cancer can take a decade if survival is used as the main outcome.
  • This result highlights the importance of performing this analysis and maximizing the use of data from globally collected clinical trials.
  • Radiographic Progression-Free Survival and Clinical Progression-Free Survival as Potential Surrogates for Overall Survival in Men With Metastatic Hormone-Sensitive Prostate Cancer.