Kaplan–Meier estimator

AACR 2024: PDC*line Pharma Presents Interim Clinical Results From Last Cohort of Patients in Phase I/II Trial with PDC*lung01 Cancer Vaccine

Retrieved on: 
Monday, April 8, 2024
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PDC*lung01 is the company’s off-the shelf therapeutic cancer vaccine candidate for Non-Small Cell Lung Cancer (NSCLC).

Key Points: 
  • PDC*lung01 is the company’s off-the shelf therapeutic cancer vaccine candidate for Non-Small Cell Lung Cancer (NSCLC).
  • The phase I/II trial (PDC-LUNG-101) aimed to assess the safety, tolerability, immunogenicity and preliminary clinical activity of PDC*lung01 in NSCLC patients, alone or in combination with anti-PD-1 treatment.
  • PDC*Line is reporting preliminary efficacy results for 19 evaluable patients in the B2 cohort that reached the 9-month PFS mark.
  • The final analysis of the clinical trial including the 45 patients from the B2 cohort will be conducted in Q3, 2024.

Iovance’s AMTAGVI™ (lifileucel) Receives U.S. FDA Accelerated Approval for Advanced Melanoma

Retrieved on: 
Friday, February 16, 2024
BRAF, SAN, Neoplasm, Cohort, Immune system, Kaplan–Meier estimator, Immunotherapy, TIL, Information, FDA, Melanoma, Food, News, Cytopenia, Infection, PD-1, AIM, National Cancer Institute, Respiratory failure, Travel, Epidemiology, Interim, Safety, Physician, BRAF V600, Patient, Journal, RECIST, ATC, Disease, Clinical trial, Kidney failure, MEK, Pharmaceutical industry

SAN CARLOS, Calif., Feb. 16, 2024 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) cell therapies for patients with cancer, today announced that the U.S. Food and Drug Administration (FDA) has approved AMTAGVI™ (lifileucel) suspension for intravenous infusion. AMTAGVI is a tumor-derived autologous T cell immunotherapy indicated for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. This indication is approved under an accelerated approval based on overall response rate (ORR) and duration of response. Iovance is also conducting TILVANCE-301, a Phase 3 trial to confirm clinical benefit.

Key Points: 
  • This indication is approved under an accelerated approval based on overall response rate (ORR) and duration of response.
  • AMTAGVI is the first and the only one-time, individualized T cell therapy to receive FDA approval for a solid tumor cancer.
  • “Given the significant unmet needs in the advanced melanoma community, we are proud to offer a personalized, one-time therapeutic option for these patients.
  • Iovance will host a conference call and live audio webcast today to discuss the FDA approval of AMTAGVI.

BridgeBio Pharma Announces U.S. Food and Drug Administration (FDA) Acceptance of New Drug Application (NDA) for Acoramidis for the Treatment of Patients with Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

Retrieved on: 
Monday, February 5, 2024
Mortality, CVH, ACM, TTR, MD, PALO, Patient, Safety, FDA, Food, Cancer, PDUFA, Doctor of Philosophy, Survival rate, NDA, Kaplan–Meier estimator, Pharmaceutical industry

PALO ALTO, Calif., Feb. 05, 2024 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s New Drug Application (NDA) for acoramidis, an investigational drug for the treatment of ATTR-CM. The application was based on positive results from ATTRibute-CM, the Company’s Phase 3 study designed to evaluate the efficacy and safety of acoramidis, an investigational, next-generation, orally-administered, highly potent, small molecule stabilizer of transthyretin (TTR). The FDA has set an action date of November 29, 2024 under the PDUFA. The FDA also notified the Company that it is not currently planning to hold an advisory committee meeting to discuss the application.

Key Points: 
  • The FDA has set an action date of November 29, 2024 under the PDUFA.
  • The FDA also notified the Company that it is not currently planning to hold an advisory committee meeting to discuss the application.
  • There is a need for more treatment options that can help fill the significant unmet need that exists for patients today.
  • The Company also received acceptance of its Marketing Authorization Application with the European Medicines Agency and is preparing for additional global regulatory submissions.

Prilenia Announces Clinical Data in Support of its Plans to Initiate Global Phase 3 Study in ALS

Retrieved on: 
Friday, January 19, 2024
Health, Genetics, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, ACT, Speech, Family, Dysarthria, Patient, Therapy, Spinal cord, HD, Drinking, ALS, Person, DSM-IV codes, Harvard Medical School, Friends, Respiration, Survival, Communication, Kaplan–Meier estimator, Quality of life, Cox, Eating, Safety, Disease, Caregiver, NIH, Hospital, Periodic breathing, Neurology, Master of Science, Massachusetts General Hospital, Bangladesh Technical Education Board, Pharmaceutical industry

The S1R is highly expressed in the brainstem and spinal cord, areas implicated in ALS and important for bulbar function and speech.

Key Points: 
  • The S1R is highly expressed in the brainstem and spinal cord, areas implicated in ALS and important for bulbar function and speech.
  • “We believe it is important for Prilenia to advance our clinical program in ALS, and we are actively planning a single, global, pivotal Phase 3 clinical trial.
  • Additional analyses from the same Phase 2 study of participants with definite or probable ALS who were also early and fast progressors were conducted.
  • Preliminary topline results in the full analysis set of this Phase 2 study were previously announced.

BriaCell Reports Unprecedented Preliminary Survival and Clinical Benefit in Antibody-Drug Conjugate (ADC) Refractory Patient Subset

Retrieved on: 
Wednesday, December 20, 2023
Immunotherapy, Rated R, Survival, Efficacy, Breast cancer, Spacecraft, ILD, Kaplan–Meier estimator, BCT, Complex conjugate, Literature, Therapy, MBC, Toxicity, Antibody-drug conjugate, TSX, Patient, PFS, ADC, Pharmaceutical industry

“We are excited with our findings of unprecedented survival and clinical benefit in very difficult-to-treat patients who failed ADCs and view our findings as a significant clinical breakthrough in the field of cancer therapy.

Key Points: 
  • “We are excited with our findings of unprecedented survival and clinical benefit in very difficult-to-treat patients who failed ADCs and view our findings as a significant clinical breakthrough in the field of cancer therapy.
  • Kaplan-Meier analysis showed median overall survival (OS) that was up to twice that reported in the literature, with some patients recording survival of over a year.
  • Progression free survival (PFS) was similar or better than that of the patients’ prior therapy in 40% of patients, highlighting clinical benefit and tolerability of the Bria-IMT™ regimen.
  • 17 of 23 patients remain alive as of today, suggesting efficacy, tolerability, and survival benefit of BriaCell’s Bria-IMT™ regimen.

BriaCell Highlights Outstanding Topline Survival and Clinical Benefit Data in Advanced Metastatic Breast Cancer at the 2023 SABCS

Retrieved on: 
Wednesday, December 6, 2023
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32 out of 42 patients treated since 2022 remain alive suggesting consistently strong survival benefit.

Key Points: 
  • 32 out of 42 patients treated since 2022 remain alive suggesting consistently strong survival benefit.
  • PHILADELPHIA and VANCOUVER, British Columbia, Dec. 06, 2023 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, is thrilled to announce continued outstanding topline survival and clinical benefit data in advanced metastatic breast cancer patients treated Bria-IMT™ in combination with an immune check point inhibitor (CPI).
  • The data is being revealed at the 2023 San Antonio Breast Cancer Symposium® held at Henry B. Gonzalez Convention Center, San Antonio, TX.
  • In summary, the consistent topline survival and clinical benefits support BriaCell’s hypothesis of additive and/or synergistic effects of immune check point inhibitors with Bria-IMT™ and support the ongoing pivotal study of our combination regimen in the treatment of advanced metastatic breast cancer.

Provectus Biopharmaceuticals Provides Updated Data on Cancer Immunotherapy PV-10 for Metastatic Uveal Melanoma

Retrieved on: 
Monday, November 13, 2023
Uveal melanoma, Disease, Mum, OTCQB, Liver, Mortality, Patient, CMR, Kaplan–Meier estimator, Nivolumab, Ipilimumab, PET-CT, Springfield Armory M1A, Acceptability, Renewable energy, Pharmaceutical industry, Medical imaging

KNOXVILLE, TN, Nov. 13, 2023 (GLOBE NEWSWIRE) -- Provectus (OTCQB: PVCT) today provided updated data from an ongoing Phase 1 clinical trial of investigational cancer immunotherapy PV-10 (rose bengal sodium) for the treatment of uveal melanoma (UM) metastatic to the liver (mUM) ( NCT00986661 ).

Key Points: 
  • KNOXVILLE, TN, Nov. 13, 2023 (GLOBE NEWSWIRE) -- Provectus (OTCQB: PVCT) today provided updated data from an ongoing Phase 1 clinical trial of investigational cancer immunotherapy PV-10 (rose bengal sodium) for the treatment of uveal melanoma (UM) metastatic to the liver (mUM) ( NCT00986661 ).
  • mUM patients enrolled in this study received 1 or more cycles of PV-10 injection into 1 or more hepatic metastases.
  • Where indicated, standard of care immune checkpoint blockade (CB), as either monotherapy pembrolizumab or the combination of ipilimumab and nivolumab (IN), was also administered.
  • Dominic Rodrigues, Vice Chair of the Provectus’s Board of Directors, said, “Objective response is uncommon and complete metabolic response is rare in metastatic uveal melanoma.

Incyte and Syndax Present Additional Data from Positive AGAVE-201 Trial at ASH Plenary Session Showing Axatilimab Efficacy Including Durable Responses in Chronic Graft-Versus-Host Disease

Retrieved on: 
Sunday, December 10, 2023
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The recommended dose of axatilimab for future trials in chronic GVHD is 0.3 mg/kg every two weeks.

Key Points: 
  • The recommended dose of axatilimab for future trials in chronic GVHD is 0.3 mg/kg every two weeks.
  • Organ-specific responses, including complete responses (CRs), were seen across all organs involved at baseline, including lower gastrointestinal (GI), upper GI, esophagus, joints/fascia, mouth, lungs, liver, eyes and skin.
  • Additionally, responses were notable in fibrosis-dominated organs, including the esophagus (78%), joints and fascia (76%), lungs (47%) and skin (27%).
  • "Full results from the AGAVE-201 trial show rapid durable responses documented in all organs and patient subgroups, with significant symptom burden reduction reported by most of these heavily-pretreated patients.

Final Round of Late-Breaking Clinical Trial Results Announced at VIVA23

Retrieved on: 
Wednesday, November 1, 2023
Female, Blood vessel, Maes, Kidney disease, Education, DCB, Freedom, MAE, TASC, Safety, Diabetes, Kaplan–Meier estimator, Research, Subgroup analysis, Meta-analysis, Pulmonary embolism, Death, BD, DVT, Detour, Clinical trial, Hypertension, Femoral vein, VIVA, TVR, Amputation, PTAB, Patient, Wynn Las Vegas, TLR, Medical imaging, Birth control, Pharmaceutical industry, Airline, SFA, Torus, EU

Below are highlights of this afternoon's 3 late-breaking clinical trial presentations.

Key Points: 
  • Below are highlights of this afternoon's 3 late-breaking clinical trial presentations.
  • A total of 1,005 patients at 74 investigational sites were treated with the Lutonix 035 DCB and were followed to 36 months.
  • Freedom from TLR at 12 months was 88.6%, and freedom from primary safety events at 30 days was 98.2%.
  • DETOUR clinical data demonstrate the clinical utility of this novel therapy in long femoropopliteal lesions.

Second Round of Late-Breaking Clinical Trial Results Announced at VIVA23

Retrieved on: 
Tuesday, October 31, 2023
Blood vessel, Patient, Angiography, Isabella Tree, Peripheral artery disease, PTA, De novo, Artery, Education, Incidence, DCB, Ioctl, BMI, AVF, CLTI, Kaplan–Meier estimator, Kidney disease, Research, HIV disease progression rates, RCT, Wound healing, BRS, Dialysis, Thrombosis, Clinical trial, Extremities, Risk, Dural arteriovenous fistula, Magnitude, Classification, VIVA, IVUS, Amputation, BTK, PAD, Wynn Las Vegas, Infection, Medical imaging, Pharmaceutical industry, Silviculture

Below are highlights of this afternoon's 3 late-breaking clinical trial presentations.

Key Points: 
  • Below are highlights of this afternoon's 3 late-breaking clinical trial presentations.
  • Results from Abbott's LIFE-BTK randomized clinical trial (RCT) demonstrate that Esprit BTK (Abbott) reduces disease progression and helps improve medical outcomes compared to balloon angioplasty, the current state of care.
  • In the LIFE-BTK trial, wound assessment was not a prespecified powered primary or secondary endpoint but rather a prespecified descriptive endpoint.
  • The trial offers the largest ischemic wound data set to date, collected systematically and adjudicated independently in a blinded fashion.