Olaparib

Rhizen Pharmaceuticals AG Announces First Patient Dosing in a Phase I/Ib Study of Its Novel PARP Inhibitor (RP12146) in Patients With Advanced Solid Tumors

Retrieved on: 
Monday, November 1, 2021

Rhizen Pharmaceuticals AG (Rhizen), a Switzerland-based privately held, clinical-stage oncology & inflammation-focused biopharmaceutical company, announced today that it has commenced dosing in a multi-center, phase I/Ib trial to evaluate its novel poly (ADP-ribose) polymerase (PARP) inhibitor (RP12146) in patients with advanced solid tumors.

Key Points: 
  • Rhizen Pharmaceuticals AG (Rhizen), a Switzerland-based privately held, clinical-stage oncology & inflammation-focused biopharmaceutical company, announced today that it has commenced dosing in a multi-center, phase I/Ib trial to evaluate its novel poly (ADP-ribose) polymerase (PARP) inhibitor (RP12146) in patients with advanced solid tumors.
  • Rhizen also announced that its PARP program is part of a larger DNA Damage Response (DDR) platform effort, which includes a preclinical-stage polymerase theta (Pol) inhibitor program.
  • Rhizen expects the platform to enable novel proprietary combinations of its PARP and Pol assets given the mechanistic synergy and opportunity across PARP resistant/refractory settings.
  • Rhizen Pharmaceuticals is an innovative, clinical-stage biopharmaceutical company focused on the discovery and development of novel oncology & inflammation therapeutics.

Genetron Health and IMPACT Therapeutics Announce Partnership to Drive Development of Synthetic Lethal Product Pipeline

Retrieved on: 
Monday, September 27, 2021

The two parties will cooperate together on research and development for synthetic lethal inhibitors that are based on new targets, and the development of companion diagnostic products.

Key Points: 
  • The two parties will cooperate together on research and development for synthetic lethal inhibitors that are based on new targets, and the development of companion diagnostic products.
  • We are pleased to have reached a partnership with IMPACT Therapeutics, whose extensive pipeline products and strong data have demonstrated potential for clinical applications.
  • IMPACT Therapeutics focuses on the research and development of targeted anti-cancer therapeutics that are based on synthetic lethality.
  • IMPACT Therapeutics is a biopharmaceutical company dedicated to the discovery and development of targeted anti-cancer therapeutics based on synthetic lethality.

Olaparib Reduces Organ Damage in Sepsis

Retrieved on: 
Monday, September 13, 2021

Sepsis is a complex disease involving the host immune response to infectious agents.Sepsis results in life-threatening organ dysfunction and has a high fatality rate in intensive care units.

Key Points: 
  • Sepsis is a complex disease involving the host immune response to infectious agents.Sepsis results in life-threatening organ dysfunction and has a high fatality rate in intensive care units.
  • Studies have shown that early organ injury in sepsis results from excessive inflammatory reactions, and uncontrolled inflammation is a key step in disease progression.Recent studies have shown that olaparib, which is FDA-approved for the treatment of some cancers, has beneficial effects on organ injury following inflammation.Nonetheless, its mechanism of action in sepsis has not been delineated.
  • Olaparib treatment also decreased the levels of pro-inflammatory mediators as well as bacterial burden in the serum, peritoneal lavage fluid, and organs.
  • The protective effects of olaparib were associated with suppression of CD14, which activates immune cells.These results suggest a new role for olaparib as a negative regulator of CD14 during organ damage in sepsis.

Outcomes4Me Incorporates NCCN Guidelines® Update into Mobile App for Breast Cancer Patients

Retrieved on: 
Wednesday, August 25, 2021

BOSTON, Aug. 25, 2021 /PRNewswire/ -- Outcomes4Me Inc. today announced it has updated its mobile app to include the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Breast Cancer V.6.2021 released last week.

Key Points: 
  • BOSTON, Aug. 25, 2021 /PRNewswire/ -- Outcomes4Me Inc. today announced it has updated its mobile app to include the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Breast Cancer V.6.2021 released last week.
  • The app serves as a digital health partner that proactively delivers timely information of value to empower patients to take more control of their care.
  • Outcomes4Me Inc. and the National Comprehensive Cancer Network (NCCN) formed a collaboration in October 2019 to integrate the NCCN Guidelines for Breast Cancer into the Outcomes4Me mobile application.
  • Outcomes4Me is on a mission to improve health outcomes by empowering patients with understandable, relevant and evidence-based information.

LYNPARZA® (olaparib) Approved in China for the Treatment of Certain Patients with BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer

Retrieved on: 
Thursday, June 24, 2021

Dose interruptions due to an AR occurred in 45% of patients receiving LYNPARZA and dose reductions due to an AR occurred in 22% of LYNPARZA patients.

Key Points: 
  • Dose interruptions due to an AR occurred in 45% of patients receiving LYNPARZA and dose reductions due to an AR occurred in 22% of LYNPARZA patients.
  • AstraZeneca and Merck are exploring additional trials in metastatic prostate cancer, including the ongoing Phase 3 PROpel trial evaluating LYNPARZA in combination with abiraterone as a first-line treatment for patients with mCRPC versus abiraterone alone.
  • Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML): Occurred in approximately 1.5% of patients exposed to LYNPARZA monotherapy, and the majority of events had a fatal outcome.
  • Do not start LYNPARZA until patients have recovered from hematological toxicity caused by previous chemotherapy (Grade 1).

LYNPARZA® (olaparib) reduced the risk of cancer recurrence by 42% in the adjuvant treatment of patients with germline BRCA-mutated high-risk early breast cancer in OlympiA Phase III trial

Retrieved on: 
Thursday, June 3, 2021

The safety and tolerability profile of LYNPARZA in this trial was in line with that observed in prior clinical trials.

Key Points: 
  • The safety and tolerability profile of LYNPARZA in this trial was in line with that observed in prior clinical trials.
  • LYNPARZA is not currently approved for the adjuvant treatment of gBRCAm high-risk HER2-negative early breast cancer.
  • PARP inhibitor, LYNPARZA (olaparib) is a targeted treatment option for patients with germline BRCA-mutated HER2-negative metastatic breast cancer.
  • Olaparib as Adjuvant Treatment in Patients with Germline BRCA-mutated High Risk HER2 Negative Primary Breast Cancer (OlympiA).

LYNPARZA® (olaparib) Reduced the Risk of Invasive Disease Recurrence or Death by 42% Versus Placebo in Adjuvant Treatment of Patients With Germline BRCA Mutations and High-Risk HER2-Negative Early Breast Cancer in Phase 3 OlympiA Trial

Retrieved on: 
Thursday, June 3, 2021

The median duration of therapy in patients who developed MDS/AML was 2 years (range: 10 years).

Key Points: 
  • The median duration of therapy in patients who developed MDS/AML was 2 years (range: 10 years).
  • Pneumonitis: Occurred in 0.8% of patients exposed to LYNPARZA monotherapy, and some cases were fatal.
  • If patients present with new or worsening respiratory symptoms such as dyspnea, cough, and fever, or a radiological abnormality occurs, interrupt LYNPARZA treatment and initiate prompt investigation.
  • Embryo-Fetal Toxicity: Based on its mechanism of action and findings in animals, LYNPARZA can cause fetal harm.

Ultimovacs Announces Phase II DOVACC Collaboration Study in Ovarian Cancer With the Nordic Society of Gynaecological Oncology – Clinical Trial Unit, the European Network of Gynaecological Oncological Trial Groups and AstraZeneca

Retrieved on: 
Monday, January 11, 2021

Ultimovacs ASA ("Ultimovacs", ticker ULTI), today announced its participation in the Phase II DOVACC collaboration study with the Nordic Society of Gynaecological Oncology Clinical Trial Unit (NSGO-CTU), the European Network of Gynaecological Oncological Trial Groups (ENGOT) and AstraZeneca, to conduct a randomized Phase II clinical trial to evaluate Ultimovacs proprietary universal cancer vaccine, UV1, in combination with AstraZenecas durvalumab and olaparib in patients with relapsed ovarian cancer.

Key Points: 
  • Ultimovacs ASA ("Ultimovacs", ticker ULTI), today announced its participation in the Phase II DOVACC collaboration study with the Nordic Society of Gynaecological Oncology Clinical Trial Unit (NSGO-CTU), the European Network of Gynaecological Oncological Trial Groups (ENGOT) and AstraZeneca, to conduct a randomized Phase II clinical trial to evaluate Ultimovacs proprietary universal cancer vaccine, UV1, in combination with AstraZenecas durvalumab and olaparib in patients with relapsed ovarian cancer.
  • The collaboration with the NSGO-CTU and ENGOT is exciting for us as they are very experienced with conducting clinical trials in the field of gynaecological oncology.
  • DOVACC is a multi-center, multinational, randomized Phase II clinical trial sponsored by the NSGO, the leading gynaecological oncology research society in the Nordic and Baltic regions.
  • Innovation Norway has granted Ultimovacs NOK 10 million, approximately EUR 1 million, to support the execution of the Phase II DOVACC study.

AstraZeneca Demonstrates Growing Leadership in Breast Cancer at SABCS with Data From Its Innovative Medicines and Robust Pipeline

Retrieved on: 
Thursday, December 3, 2020

In clinical studies, of the 234 patients with unresectable or metastatic HER2-positive breast cancer treated with ENHERTU, ILD occurred in 9% of patients.

Key Points: 
  • In clinical studies, of the 234 patients with unresectable or metastatic HER2-positive breast cancer treated with ENHERTU, ILD occurred in 9% of patients.
  • AstraZeneca aims to continue to transform outcomes for HR-positive breast cancer with foundational medicines fulvestrant and goserelin and the next-generation SERD and potential new medicine AZD9833.
  • PARP inhibitor, LYNPARZA (olaparib), was the first targeted treatment option for metastatic breast cancer patients with an inherited BRCA mutation.
  • AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

Lynparza® (olaparib) Receives Health Canada Approval for the Treatment of BRCA or ATM Gene-Mutated Metastatic Castration-Resistant Prostate Cancer

Retrieved on: 
Wednesday, November 25, 2020

The Notice of Compliance was granted under priority review and marks the first Health Canada approval of a PARP inhibitor in prostate cancer.

Key Points: 
  • The Notice of Compliance was granted under priority review and marks the first Health Canada approval of a PARP inhibitor in prostate cancer.
  • "This new approval offers patients a much-needed new treatment option, and also reinforces the importance of BRCA and ATM testing."
  • The Health Canada approval of Lynparza for BRCA or ATM gene-mutated mCRPC was based on data from Cohort A of the global Phase III PROfound trial.
  • Based on the available clinical trial data, a causal association between Lynparza treatment and VTE including pulmonary embolism has not been established.