PROSTATE CANCER


Associated tags: Clinical Cancer Research, Patient, PARP, JCO, BRCA2, Disease, Prostate cancer, Metastasis, American Cancer Society, ATM, Research, National Cancer Institute, Safety, Health, Cancer, Pharmaceutical industry, Biotechnology, Pharmaceutical, Oncology

Locations: US, EUROPE

OncoC4 Announces First Patient with Advanced Prostate Cancer Dosed in Phase 1/2 Trial of BioNTech-partnered BNT316/ONC-392 Program

Retrieved on: 
Thursday, February 22, 2024
Principal, BioNTech, Safety, Lutetium, Patient, Prostate cancer, Survival, Disease, NYU Langone Health, Cancer, Pharmaceutical industry

ROCKVILLE, Md., Feb. 22, 2024 (GLOBE NEWSWIRE) -- OncoC4, Inc. (“OncoC4”) today announced that the first patient with metastatic castration resistant prostate cancer (“mCRPC”) has been dosed in a Phase 1/2 trial evaluating the anti-CTLA-4 antibody candidate BNT316/ONC-392 (gotistobart) in combination with radioligand therapy, lutetium (177Lu) vipivotide tetraxetan (Pluvicto®).

Key Points: 
  • ROCKVILLE, Md., Feb. 22, 2024 (GLOBE NEWSWIRE) -- OncoC4, Inc. (“OncoC4”) today announced that the first patient with metastatic castration resistant prostate cancer (“mCRPC”) has been dosed in a Phase 1/2 trial evaluating the anti-CTLA-4 antibody candidate BNT316/ONC-392 (gotistobart) in combination with radioligand therapy, lutetium (177Lu) vipivotide tetraxetan (Pluvicto®).
  • BNT316/ONC-392 is being jointly developed by BioNTech and OncoC4.
  • The trial will initially evaluate the safety of BNT316/ONC-392 in combination with lutetium (177Lu) vipivotide tetraxetan and help inform the preferred dosage.
  • The trial will assess whether the combination increases progression free survival over the current standard of care as the primary endpoint.

Perspective Therapeutics Announces Exclusive License Agreement with Mayo Clinic for New Radiopharmaceutical Platform for Prostate Cancer Treatment

Retrieved on: 
Friday, January 5, 2024
Molecular imaging, Associate, Perspective, PSMA, Workflow, Research, FRSC, PET, Tissue, Prostate cancer, Mouse, MD, Doctor of Philosophy, Health, Education, Radiology, Therapy, RPT, Mayo Clinic, Prostate, Neoplasm, Kidney, Patient, CATX, Radiation, Medical imaging

SEATTLE, Jan. 05, 2024 (GLOBE NEWSWIRE) --  Perspective Therapeutics, Inc. (“Perspective” or “the Company”) (NYSE AMERICAN: CATX), announced today that it has entered into a patent license agreement with Mayo Clinic for the rights to the PSMA Alpha-PET DoubLET platform technology for the treatment of PSMA-expressing cancers, with an initial focus on prostate.

Key Points: 
  • The PSMA Alpha-PET DoubLET platform technology represents a potential leap forward in the field of prostate cancer diagnostics and treatment.
  • This leading radiopharmaceutical platform provides detailed PET imaging-based diagnosis and dosimetry using long-lived copper-64 (64Cu) for imaging and alpha-particle targeted RPT using lead-212 (212Pb).
  • “This innovative approach developed by Mayo Clinic allows for more precise and personalized treatment plans,” said Thijs Spoor, Chief Executive Officer at Perspective Therapeutics.
  • Mayo Clinic will use any revenue it receives to support its not-for-profit mission in patient care, education and research.

Lantheus and POINT Biopharma Announce Positive Topline Results from Pivotal SPLASH Trial in Metastatic Castration-Resistant Prostate Cancer

Retrieved on: 
Monday, December 18, 2023
House (season 5), Risk, PSMA, NDA, Cancer, HR, PNT, Death, RLT, CTCAE, SPLASH, Patient, Safety, BC Cancer Agency, LNTH, Pharmaceutical industry

BEDFORD, Mass., and INDIANAPOLIS, Dec. 18, 2023 (GLOBE NEWSWIRE) -- December 18, 2023 – Lantheus Holdings, Inc. (Lantheus) (NASDAQ: LNTH) and POINT Biopharma Global Inc. (POINT) (NASDAQ: PNT) today announced statistically significant topline results from the pivotal Phase 3 SPLASH study evaluating the efficacy and safety of 177Lu-PNT2002, a prostate-specific membrane antigen (PSMA)-targeted radioligand therapy (RLT), in patients with metastatic castration-resistant prostate cancer (mCRPC) after progression on an androgen receptor pathway inhibitor (ARPI).

Key Points: 
  • BEDFORD, Mass., and INDIANAPOLIS, Dec. 18, 2023 (GLOBE NEWSWIRE) -- December 18, 2023 – Lantheus Holdings, Inc. (Lantheus) (NASDAQ: LNTH) and POINT Biopharma Global Inc. (POINT) (NASDAQ: PNT) today announced statistically significant topline results from the pivotal Phase 3 SPLASH study evaluating the efficacy and safety of 177Lu-PNT2002, a prostate-specific membrane antigen (PSMA)-targeted radioligand therapy (RLT), in patients with metastatic castration-resistant prostate cancer (mCRPC) after progression on an androgen receptor pathway inhibitor (ARPI).
  • “There is an urgent unmet need for targeted treatment options for mCRPC patients, particularly for those whose cancer has progressed on androgen receptor pathway inhibitors,” said Dr. Kim Chi, SPLASH Principal Investigator, Medical Oncologist, BC Cancer.
  • At the time of the analysis, interim overall survival (OS) results were immature (46% of protocol-specified target OS events reached), the HR was 1.11.
  • The companies expect additional, follow-up data in 2024 prior to the potential submission of a New Drug Application (NDA).

Lantheus and POINT Biopharma Announce Positive Topline Results from Pivotal SPLASH Trial in Metastatic Castration-Resistant Prostate Cancer

Retrieved on: 
Monday, December 18, 2023
House (season 5), Risk, PSMA, NDA, Cancer, HR, PNT, Death, RLT, CTCAE, SPLASH, Patient, Safety, BC Cancer Agency, LNTH, Pharmaceutical industry

and INDIANAPOLIS, Dec. 18, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (Lantheus) (NASDAQ: LNTH) and POINT Biopharma Global Inc. (POINT) (NASDAQ: PNT) today announced statistically significant topline results from the pivotal phase 3 SPLASH study evaluating the efficacy and safety of 177Lu-PNT2002, a prostate-specific membrane antigen (PSMA)-targeted radioligand therapy (RLT), in patients with metastatic castration-resistant prostate cancer (mCRPC) after progression on an androgen receptor pathway inhibitor (ARPI).

Key Points: 
  • and INDIANAPOLIS, Dec. 18, 2023 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (Lantheus) (NASDAQ: LNTH) and POINT Biopharma Global Inc. (POINT) (NASDAQ: PNT) today announced statistically significant topline results from the pivotal phase 3 SPLASH study evaluating the efficacy and safety of 177Lu-PNT2002, a prostate-specific membrane antigen (PSMA)-targeted radioligand therapy (RLT), in patients with metastatic castration-resistant prostate cancer (mCRPC) after progression on an androgen receptor pathway inhibitor (ARPI).
  • “There is an urgent unmet need for targeted treatment options for mCRPC patients, particularly for those whose cancer has progressed on androgen receptor pathway inhibitors,” said Dr. Kim Chi, SPLASH Principal Investigator, Medical Oncologist, BC Cancer.
  • At the time of the analysis, interim overall survival (OS) results were immature (46% of protocol-specified target OS events reached), the HR was 1.11.
  • The companies expect additional, follow-up data in 2024 prior to the potential submission of a New Drug Application (NDA).

Vaccitech Doses First Patient in PCA001, a Prostate Cancer Phase 1/2 Clinical Trial of VTP-850 Immunotherapeutic Candidate in Men with Rising PSA after Definitive Local Therapy

Retrieved on: 
Monday, June 12, 2023
Antigen, Prostate-specific antigen, University, Oxford, Prostate cancer, Cancer, Prostate, Autoimmunity, Patient, STEAP1, Immune system, PAP, 5T4, Recurrence, PSA, Safety, Disease, Vaccine, Vaccitech

PCA001 is a multi-centre, Phase 1/2 clinical trial designed to determine the recommended Phase 2 regimen and evaluate the safety, efficacy, as measured by prostate-specific antigen (PSA) response, and T cell response of VTP-850 monotherapy in men with rising PSA after definitive local therapy for their disease (i.e., biochemical recurrence).

Key Points: 
  • PCA001 is a multi-centre, Phase 1/2 clinical trial designed to determine the recommended Phase 2 regimen and evaluate the safety, efficacy, as measured by prostate-specific antigen (PSA) response, and T cell response of VTP-850 monotherapy in men with rising PSA after definitive local therapy for their disease (i.e., biochemical recurrence).
  • VTP-850 is a next-generation prostate cancer immunotherapeutic candidate which utilizes Vaccitech’s sequential dosing approach of two proprietary nonreplicating viral vectors, ChAdOx and MVA.
  • The first phase of the trial is enrolling participants in the US, with plans to open further sites in Italy and Spain.
  • “When the immune system targets multiple molecules on tumor cells, it is generally harder for tumor cells to escape destruction by the immune system.”

Merck and AstraZeneca Present Final Results of Key Secondary Overall Survival Endpoint From Phase 3 PROpel Trial at 2023 American Society of Clinical Oncology Genitourinary Cancers Symposium

Retrieved on: 
Thursday, February 16, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, MSD, Prednisolone, MRK, NYSE, Risk, AstraZeneca, Standard of care, OS, RPF, Death, HIV disease progression rates, Prednisone, Silviculture, Medical imaging, Pharmaceutical industry, Merck

In this updated analysis, the most common adverse events (AEs) (≥20%) were anemia (49.7%), fatigue (38.7%), nausea (30.7%), back pain (21.6%) and diarrhea (20.6%).

Key Points: 
  • In this updated analysis, the most common adverse events (AEs) (≥20%) were anemia (49.7%), fatigue (38.7%), nausea (30.7%), back pain (21.6%) and diarrhea (20.6%).
  • Approximately 17% of patients who received LYNPARZA in combination with abi/pred discontinued treatment due to an AE.
  • With limited treatment options for these patients, we recognize the critical need for therapies that can delay disease progression.
  • We are proud of our collaboration with AstraZeneca, as we work together to advance pending regulatory reviews and bring a new treatment option to the prostate cancer community.”

Clovis Oncology Presents Data from TRITON3 Phase 3 Trial of Rubraca® (rucaparib) at the 29th Annual Prostate Cancer Foundation Scientific Retreat

Retrieved on: 
Thursday, October 27, 2022
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology

Clovis Oncology, Inc. (NASDAQ: CLVS) today announced the presentation of data from the TRITON3 Phase 3 trial in men with metastatic castration-resistant prostate cancer with BRCA or ATM mutations.

Key Points: 
  • Clovis Oncology, Inc. (NASDAQ: CLVS) today announced the presentation of data from the TRITON3 Phase 3 trial in men with metastatic castration-resistant prostate cancer with BRCA or ATM mutations.
  • TRITON3 ( NCT02975934 ) is a Phase 3, multicenter, open-label, randomized trial of Rubraca in patients with chemotherapy-nave mCRPC.
  • TRITON3 was designed as a Phase 3 trial to confirm and expand the efficacy data from TRITON2 in an earlier treatment setting against a relevant control arm.
  • The American Cancer Society estimates that approximately 268,000 men in the US will be diagnosed with prostate cancer in 2022, and the GLOBOCAN Cancer Fact Sheets estimated that approximately 473,000 men in Europe were diagnosed with prostate cancer in 2020.

TRITON3 Phase 3 Trial of Rubraca® (rucaparib) Achieves Primary Endpoint in Men with Metastatic Castration-Resistant Prostate Cancer with BRCA or ATM Mutations

Retrieved on: 
Monday, October 3, 2022
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, FDA, Clinical Trials

TRITON3 is a Phase 3, multicenter, open-label, randomized trial of Rubraca in patients with chemotherapy-nave mCRPC.

Key Points: 
  • TRITON3 is a Phase 3, multicenter, open-label, randomized trial of Rubraca in patients with chemotherapy-nave mCRPC.
  • The primary endpoint was rPFS by IRR, in patients with mutations in BRCA1, BRCA2 or ATM.
  • TRITON3 was designed as a Phase 3 trial to confirm and expand the efficacy data from TRITON2 in an earlier treatment setting against a relevant control arm.
  • Following is a summary of the primary efficacy analyses of rPFS by independent radiologic review (IRR), the primary analysis of TRITON3.

Forma Therapeutics’ FT-7051 is Well-tolerated and Demonstrates Evidence of Activity in Initial Results from Ongoing Phase 1 Courage Study in Men with Metastatic Castration-resistant Prostate Cancer

Retrieved on: 
Thursday, October 7, 2021
Biotechnology, General Health, Health, Pharmaceutical, Oncology, Prostate, Private Securities Litigation Reform Act, Man, Absorption, MCRPC, Grade, Ars, BRP Ramon Alcaraz (PS-16), Male, Prostate cancer, Conference, CBP, AR, BioMed Central, Protein, American Cancer Society, Veni, vidi, vici, John Worsfold, Sickle cell disease, Degenerative disease, LinkedIn, Safety, Cancer, HIV disease progression rates, SEC, Research, Pharmacology, Mortality, U.S. Securities and Exchange Commission, Radiation, PSA, Security (finance), AACR, Therapy, Survival, Forma, Patient, Disease, Nasdaq, Pharmaceutical industry, Medical imaging, Birth control, CBP/p300, Prostate Cancer, Forma Therapeutics, CBP/P300, PROSTATE CANCER, FORMA THERAPEUTICS

Preliminary results reported today include data as of Sept. 1, 2021, from eight men enrolled in the trial.

Key Points: 
  • Preliminary results reported today include data as of Sept. 1, 2021, from eight men enrolled in the trial.
  • Three patients remain on study; five patients left the study (four due to disease progression and one withdrawal of consent).
  • The 150 mg dose achieved drug concentrations that approached the predicted efficacious dose based on modeling with preclinical results.
  • Skin biopsies of the men participating in the study demonstrated a reduction in H3K27AC, a marker of activity in the CBP/p300 pathway, the target of FT-7051.

NUBEQA® (darolutamide) Impact on Local Symptoms Evaluated in Men with Non-Metastatic Castration-Resistant Prostate Cancer (nmCRPC)  

Retrieved on: 
Tuesday, September 14, 2021
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Prostate, Man, Quality of life, MFS, ADT, CPI, Tissue, Patient, Research, Hematuria, European Organization for Quality, Phase, Medical director, Severe cutaneous adverse reactions, Physician, Pneumonia, Urinary retention, The Rheumatoid Arthritis Quality of Life Questionnaire, FACS, Treatment, Pharmaceutical industry, Medical imaging, NUBEQA® (darolutamide)2, Prostate Cancer, Oncology at Bayer, Bayer, NUBEQA® (DAROLUTAMIDE)2, PROSTATE CANCER, ONCOLOGY AT BAYER, BAYER

Local symptoms from the prostate and surrounding tissues can be very detrimental to patients QoL.

Key Points: 
  • Local symptoms from the prostate and surrounding tissues can be very detrimental to patients QoL.
  • NUBEQA (darolutamide) is an androgen receptor inhibitor indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer.
  • Effect of Other Drugs on NUBEQA Combined P-gp and strong or moderate CYP3A4 inducers decrease NUBEQA exposure, which may decrease NUBEQA activity.
  • Impact of darolutamide on local symptoms in patients with nonmetastatic castration-resistant prostate cancer [abstract].