Author Interviews, Ophthalmology / 30.07.2020

MedicalResearch.com Interview with: CARL D. REGILLO, MD, FACS Carl D. Regillo, MD, FACS Chief, Retina Service Wills Eye Hospital MedicalResearch.com: What is the background for the Phase III Archway study? Would you briefly explain what Neovascular Age-Related Macular Degeneration means?  Genentech announced in late July the results from the Phase III Archway study evaluating Port Delivery System (PDS) with ranibizumab (PDS) in people living with neovascular or “wet” age-related macular degeneration (nAMD) which showed PDS enabled 98.4% of people to go six months between treatments, while achieving vision outcomes equivalent to those receiving monthly ranibizumab eye injections, a current standard of care. AMD is a condition that affects the part of the eye that provides sharp, central vision needed for activities like reading and is a leading cause of blindness for people age 60 and over in the U.S. Neovascular AMD is an advanced form of AMD that can cause rapid and severe vision loss. Approximately 11 million people in the United States have some form of AMD and of those, about 1.1 million have nAMD. 
Author Interviews, COVID -19 Coronavirus, Infections, Pediatrics / 07.04.2020

genentech MedicalResearch.com: What are the applicable pediatric and post-exposure indications? Response: We recently announced that the U.S. FDA has accepted a New Drug Application (NDA) as well as two supplemental New Drug Applications (sNDA) for Xofluza® (baloxavir marboxil). The FDA accepted an NDA for a new formulation of Xofluza as one-dose granules for oral suspension (2 mg/mL), potentially offering a more convenient option for children and those who have difficulty swallowing. In addition, the application seeks approval of Xofluza for the treatment of acute uncomplicated influenza in otherwise healthy children aged one to less than 12 years of age who have been symptomatic for no more than 48 hours. The FDA also accepted an sNDA for post-exposure prophylaxis of influenza in people one year of age and older for both the oral suspension and currently-available tablet formulation.
Author Interviews, Hematology, Lymphoma / 12.12.2019

MedicalResearch.com Interview with: Genentech Priscilla White, spokesperson Senior Manager, Corporate Relations Genentech MedicalResearch.com: What is the background for this study? What are the main findings?
  • Response: Mosunetuzumab is a T-cell engaging bispecific antibody designed to target CD20-positive B-cell blood cancers, by binding to both CD20 (on the surface of B-cells) and CD3 (on the surface of T-cells).
  • Analyses from the ongoing Phase I/Ib GO29781 study indicate that mosunetuzumab can produce durable responses in patients who have relapsed or who are refractory to prior treatment(s), including those who have relapsed or who are resistant to CAR T-cell therapy.
  • Results from this dose-escalation study showed encouraging efficacy with an objective response rate (ORR) of 62.7 percent (n=42/67) in slow-growing Non-Hodgkin Lymphoma and 37.1 percent (n=46/124) in aggressive NHL across all dose levels assessed.
  • Additionally, data demonstrated a complete response (CR) rate of 43.3 percent (n=29/67) in slow-growing NHL and 19.4 percent (n=24/124) in aggressive NHL. CRs showed durability, with 82.8 percent (n=24/29) of patients with slow-growing NHL remaining in remission up to 26 months off initial treatment and 70.8 percent (n=17/24) of patients with aggressive NHL, remaining in remission up to 16 months off initial treatment.
  • Of the participants who received prior CAR T-cell therapy, the ORR was 38.9 percent (n=7/18), and 22.2 percent (n=4/18) achieved a CR.
  • Adverse reactions included cytokine release syndrome (CRS) in 28.9 percent of patients with 20.0 percent at Grade 1 and 1.1 percent at Grade 3. Grade 3 neurological adverse events occurred in 3.7 percent of patients.
Author Interviews, Cancer Research, Genentech, Leukemia / 25.03.2019

MedicalResearch.com Interview with: [caption id="attachment_48117" align="alignleft" width="200"]Nancy Valente, M.D.VP of Global Hematology DevelopmentGenentech Dr. Valente[/caption] Nancy Valente, M.D. VP of Global Hematology Development Genentech Dr. Valenta discusses the announcement of the submission by Genentech of a supplemental New Drug Application to the FDA for Venclexta plus Gazyva for people with previously untreated chronic lymphocytic leukemia  with co-existing medical conditions. MedicalResearch.com: What is the background for this study? What are the main findings of the Phase III CLL14 study?  Response: We completed the submission of a supplemental New Drug Application (sNDA) to the FDA for Venclexta® (venetoclax) in combination with Gazyva® (obinutuzumab) in people with previously untreated chronic lymphocytic leukemia (CLL) and co-existing medical conditions. CLL is the most common form of adult leukemia and more than 20,000 new cases will be diagnosed in the U.S. this year. The sNDA is based on data from the Phase III CLL14 study, which evaluated fixed-duration Venclexta in combination with Gazyva in people with previously untreated CLL. Results showed this chemotherapy-free combination can help people with previously untreated CLL live significantly longer without their disease worsening (progression-free survival; PFS) compared to standard-of-care Gazyva plus chlorambucil. The FDA is reviewing our application under the Real-Time Oncology Review (RTOR) pilot program, which is exploring a more efficient review process to ensure safe and effective treatments are available to patients as early as possible. 
Author Interviews, Flu - Influenza, Genentech / 30.10.2018

MedicalResearch.com Interview with: [caption id="attachment_45220" align="alignleft" width="200"]Mark D. Eisner, MD, MPH Vice President, Product Development Immunology Infectious Disease and Ophthalmology Genentech  Dr. Mark Eisner[/caption] Mark D. Eisner, MD, MPH Vice PresidentProduct Development Immunology, Infectious Disease and Ophthalmology Genentech Dr. Eisner discusses the announcement that the FDA has approved XOFLUZA™ (baloxavir marboxil) for the treatment of acute, uncomplicated influenza. MedicalResearch.com: What is the background for this announcement? Response: Each year, an estimated 3-11 percent of the U.S. population gets the flu, and it can be very serious, resulting in hospitalization or even death. Since 2010, the Centers for Disease Control and Prevention (CDC) estimates that the flu has resulted annually in 9.2 to 35.6 million illnesses, 140,000 to 900,000 hospitalizations and 12,000 to 80,000 deaths. The severity of last year’s flu season underscores the need for new medical options beyond currently available antivirals. XOFLUZA was granted Priority Review in June 2018 based on results from the Phase III CAPSTONE-1 study of a single dose of XOFLUZA compared with placebo or oseltamivir 75 mg, twice daily for five days, in otherwise healthy people with the flu, as well as results from a placebo-controlled Phase II study in otherwise healthy people with the flu.
Author Interviews, Flu - Influenza, Genentech / 26.07.2018

MedicalResearch.com Interview with: [caption id="attachment_43512" align="alignleft" width="200"]Mark Eisner MD MPH Vice President and Global Head of Respiratory Actemra, ID, and Metabolism Clinical Development at Genentech Professor of Clinical Medicine University of California, San Francisco Dr. Mark Eisner[/caption] Mark Eisner MD MPH Mark D. Eisner, MD, MPH Vice President, Product Development Immunology, Infectious Disease, and Ophthalmology Genentech   MedicalResearch.com: What is the background for this study? Would you briefly explain how baloxavir marboxil differs from other flu treatments?  Response: CAPSTONE-2 is a Phase III multicenter, randomized, double-blind study that evaluated a single dose of baloxavir marboxil compared with placebo and oseltamivir in people 12 years and older who are at a high risk of complications from the flu. The high risk inclusion criteria in CAPSTONE-2 were aligned with the Centers for Disease Control and Prevention (CDC), which defines people at high risk for serious flu complications to include adults 65 years of age or older, or those who have conditions such as asthma, chronic lung disease, diabetes or heart disease. For these people, flu can lead to hospitalization or even death. Participants enrolled in the study were randomly assigned to receive a single dose of 40 mg or 80 mg of baloxavir marboxil (according to body weight), placebo or 75 mg of oseltamivir twice a day for five days. The FDA recently accepted a New Drug Application (NDA) and granted Priority Review to baloxavir marboxil as a single-dose, oral treatment for acute, uncomplicated influenza in people 12 years and older. The NDA was based on results from the Phase III CAPSTONE-1 study of a single dose of baloxavir marboxil compared with placebo or oseltamivir 75 mg, twice daily for five days, in otherwise healthy people with the flu. Results from a placebo-controlled Phase II study in otherwise healthy people with the flu were included as supporting data in the NDA. The FDA is expected to make a decision on approval by December 24, 2018. Baloxavir marboxil is a first-in-class, single-dose investigational oral medicine with a novel proposed mechanism of action designed to target the influenza A and B viruses, including oseltamivir-resistant strains and avian strains (H7N9, H5N1). Unlike other currently available antiviral treatments, baloxavir marboxil is the first in a new class of antivirals designed to inhibit the cap-dependent endonuclease protein within the flu virus, which is essential for viral replication. By inhibiting this protein, baloxavir marboxil prevents viral replication earlier in the flu virus life cycle.