Author Interviews, JAMA, Ovarian Cancer / 04.08.2023

MedicalResearch.com Interview with: Zai LabRafael Amado, M.D. President, head of Global Oncology Research and Development Zai Lab MedicalResearch.com: What is the background for this study? Response: Zai lab is focused on discovering and developing innovative therapies that will help address medical conditions where there are serious unmet needs. Advanced ovarian cancer, with a low survival and high recurrence rate, is a key focus of our oncology R&D research. In addition to our own discovery program, as part of our open innovation model we partner with companies to license drugs for patients in China and co-develop therapies to address leading causes of cancer death. We currently have a license and collaboration agreement with GSK for the development and commercialization of ZEJULA (niraparib) in mainland China, Hong Kong, and Macau. PRIME was a follow-on study to a previously conducted study called PRIMA, which demonstrated clinical benefit of niraparib in newly diagnosed patients with advanced ovarian cancer regardless of biomarker status. The PRIMA study enrolled a population at high risk of recurrence. Thirty-five percent of patients in PRIMA received an individualized starting dose (ISD) of niraparib based on their baseline weight and platelet count. To further evaluate the efficacy and safety of niraparib with an ISD in a broad population, we decided to conduct the PRIME study.¬†We wanted to explore further whether we could decrease toxicity using an ISD and how it would affect clinical outcomes. The Phase 3 PRIME study was conducted at 29 hospitals in mainland China. PRIME was a randomized, placebo-controlled trial designed to evaluate the efficacy and safety of niraparib at an ISD as first-line maintenance therapy in a broad range of patients with newly diagnosed advanced ovarian cancer. All patients in PRIME received an ISD based on their baseline body weight and platelet count. (more…)
Author Interviews, Breast Cancer, Cancer Research, JAMA, Race/Ethnic Diversity / 09.03.2023

MedicalResearch.com Interview with:
Hyuna Sung, PHDHyuna Sung, PHD Senior Principal Scientist, Cancer Surveillance Research American Cancer Society Kennesaw, GA 30144
  MedicalResearch.com: What is the background for this study? Response: Triple-negative breast cancer (TNBC) accounts for 10% to 20% of all breast cancer diagnoses in the US. This subtype of breast cancer tends to spread faster and has fewer treatment options. In the US, Black women are about two-fold more likely than White women to develop TNBC. (more…)
Author Interviews, Immunotherapy, JAMA, Melanoma / 03.11.2022

MedicalResearch.com Interview with: Olivier van Not Scientific Bureau, Dutch Institute for Clinical Auditing Leiden, the Netherlands Department of Medical Oncology University Medical Centre Utrecht Utrecht, the Netherlands MedicalResearch.com: What is the background for this study? Response: The introduction of immune checkpoint inhibitors (ICIs) has significantly improved the survival of advanced melanoma patients. Treatment with these ICIs can lead to immune-related adverse events, also known as toxicity. This toxicity is graded from 1 (mild) to 5 (fatal) and examples of these toxicities are hepatitis and colitis. Since these toxicities can be life threatening and become chronic, they require treatment with immunosuppressants such as corticosteroids or anti-TNF. In a previous study of melanoma patients treated with different types of immune checkpoint inhibitors [Verheijden et al, Clin Cancer Research 2020] we found survival to be better for patients experiencing immune-related toxicity, which is in line with many other studies in several cancer types and a recent meta-analysis. (more…)