Vol 18, No 2 2020
Medical Intelligence (continued)
This indication is approved under accelerated approval based on pharmacokinetic data, the relationship of exposure to efficacy and the relationship of exposure to safety. Continued approval for this dosing may be contingent upon verification and description of clinical benefit in the confirmatory trials. This new dosage option will be available in addition to the current dose of 200 mg every three weeks (Q3W).
“The important social distancing measures for COVID-19 have created a number of challenges for people with cancer, including keeping to planned treatment schedules,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “Today’s approval of an every six-week dosing schedule for Keytruda gives doctors an option to reduce how often patients are at the clinic for their treatment.”
Regenerative Medicine Advanced Therapy Designation awarded to ilixadencel in kidney cancer
STOCKHOLM—Immunicum has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for the company’s lead candidate, ilixadencel, a cell-based, off-the-shelf immune primer for the treatment of metastatic renal cell carcinoma (mRCC). The FDA’s decision was made based on the previously communicated results from the Phase 2 MERECA clinical trial that evaluated the safety and efficacy of ilixadencel in combination with Sutent® (sunitinib) in patients with newly diagnosed mRCC. Advantages of the RMAT designation include all the benefits of the Fast Track and Breakthrough Therapy Designation programs, including guidance and early interactions with the FDA to discuss potential surrogate or intermediate endpoints to support accelerated approval as well as potential ways to satisfy post-approval requirements.
Established in 2017 under the 21st Century Cures Act in the US, RMAT designation is an expedited program designed to facilitate the development and review of regenerative medicine therapies intended to address an unmet medical need in patients with serious conditions. An investigational regenerative medicine therapy (e.g. cell or gene therapy) is eligible for RMAT designation if it is intended to treat, modify, reverse or cure a serious condition and preliminary clinical evidence indicates that the drug or therapy has the potential to address unmet medical needs for such a disease or condition. As a cell therapy medicinal product, ilixadencel falls within the definition of a regenerative medicine therapy.
The latest results of the Phase 2 MERECA trial were presented in February at the ASCO-SITC Clinical Immuno-Oncology Symposium 2020 in Orlando, Florida. As of December 2019, the patient follow up data indicated a separation in Kaplan-Meier survival curves in favor of the ilixadencel treatment group in line with the projected separation based on the data from July 2019. The median OS value could not be calculated yet in either group as the data are not mature. The confirmed ORR for the ilixadencel treatment group was 42.2% (19/45) versus 24.0% (6/25) for the sunitinib control group.
KCA initiative brings personalized nutrition support to patients and caregivers
HOUSTON – The Kidney Cancer Association (KCA) is partnering with Savor Health® to bring Ina®, The Intelligent Nutrition Assistant to the kidney cancer community. Ina® provides personalized, evidence-based nutrition support “on demand” to help people living with cancer stay well-nourished and manage symptoms.
Developed by oncology-credentialed medical experts, Ina® is available 24/7 via SMS text. Patients and caregivers can text their questions on nutrition and symptom management from their cell phone and Ina® will respond with personalized nutrition tips, recipes, and answers – no phone calls or appointments necessary. All knowledge and advice is based on scientific evidence and the training of oncology-credentialed registered dietitians, nurses, and physicians who are experts in the needs of cancer patients. Ina® is compliant with the Health Insurance Portability and Accountability Act (HIPAA). It brings a much-needed cancer-specific nutrition resource to the kidney cancer community. A 2015 study in the Journal of Cachexia, Sarcopenia and Muscle showed that 31.7% of metastatic renal cell carcinoma (mRCC) patients were classified as being at risk of malnutrition. Poor nutrition status and low body mass index (BMI) scores were predictors of decreased survival and poor quality of life among kidney cancer patients.
“The Kidney Cancer Association is delighted to share this innovative new resource with the kidney cancer community,” said Gretchen E. Vaughan, President and CEO of the KCA. “Nutrition is a major concern for people living with cancer and easy, quick, and relevant advice is crucial. Especially now, when other aspects of life may feel outside of their control, we hope that anyone impacted by kidney cancer can feel empowered by the knowledge Ina provides.”
This partnership supports the KCA’s mission to provide support and resources that empower people to make informed decisions about their health. For more information on how to use Ina®, please visit the KCA’s website at https://www.kidneycancer.org/ina-by-savor-health. KCJ