MDNews - San Antonio

++++++++++++++++++++++ + +++ + +++ ++++++++++++++++++++++ ❮ AROUND TOWN FDA APPROVES DRUG THAT WAS FIRST TESTED BY SA-BASED START A breakthrough for patients with advanced melanoma, pembrolizumab, will now be a part of standard-of-care for patients with advanced melanoma. Patients with advanced melanoma will soon have access to a new treatment op - tion, thanks to FDA approval of MK-3475, or pembrolizumab. The drug, a Merck compound, underwent its initial test- ing at South Texas Accelerated Research Therapeutics (START) in San Antonio. The principal investigator on the trial was Amita Patnaik, MD, and the first 17 patients treated with the drug, as well as the first responses, were at START. Merck plans to market pembrolizumab under the brand name Keytruda. Dr. Patnaik, Associate Director of Clinical Research at START in San Antonio, calls this drug "transformative" in the treatment of advanced melanoma, which causes about 75 percent of the skin cancer deaths in the U.S. and has proven to be very resistant to traditional forms of treatment. "Approval of this drug is wonderful news for cancer patients and the doctors who treat them," Dr. Patnaik says. "A break - through of this proportion happens rarely and will give both oncologists and patients a significant, new treatment option and will likely become the standard of care for patients with late-stage melanoma." Pembrolizumab is a PD-1 inhibitor (programmed death receptor-1), which is thought to work by stimulating the patient's own immune system to mount a T cell-me - diated immune response against the cancer. Pembrolizumab is one of a number of what are called "targeted therapies," which re- searchers at START are optimistic can "zero in" on specific malignant cells, without the dangerous and debilitating side effects of radiation and chemotherapy. "This FDA approval is also important news for San Antonio," Patnaik says. "In the world of cancer research, San Antonio is ground zero, and what many may not realize is that a large propor - tion of FDA-approved anticancer agents were first used in patients here — not in cancer centers in Houston or New York or anywhere else. "In other words," Patnaik continues, "some of the most recognizable names in cancer therapies were tested by the researchers at START in San Antonio." START's researchers — Dr. Patnaik, Anthony Tolcher, MD, Kyriakos Papadopoulos, MD, and Drew Rasco, MD — have had direct, hands-on involvement with the clinical development of more than 18 anticancer drugs that, in the past 16 years, have obtained FDA approval. These drugs include erlotinib, gefitinib, sorafenib, panitumumab, temsirolimus, lapatinib, bortezomib, vorinostat, pemetrexed, abi - raterone, ixabepilone, cabazitaxel, eribulin, trametinib, Kadycla, Stivarga, Zaltrap and carfilzomib. Because of the work being done by START, San Antonio's reach has been global. START serves patients and leads re - search efforts from its headquarters in the South Texas Medical Center and operates four Phase I clinical research centers on three continents, using an integrated team of researchers who work around the clock to develop the most effective treatment therapies. This innovative global approach to research has one singular goal — to ac - celerate the development of new drugs for the treatment and eventual cure of cancer. With Phase I centers strategically situated in Madrid, Shanghai and the U.S., START's team of physicians and researchers are using all 24 hours of the clock. When one center closes for the day, another one is just beginning. In April 2013, pembrolizumab was granted breakthrough therapy (BT) designation by the FDA, a designation reserved for drugs considered to offer a significant improvement in the safety or efficacy of the treatment of a serious con - dition. Breakthrough therapy designation generally shortens the drug's FDA review period from 10 months to six months. Data on MK-3475 (pembrolizumab) were first presented at the 2012 ASCO Annual Meeting by Dr. Patnaik and her colleagues and subsequently published in The New England Journal of Medicine in July 2013. These early results looked at 135 patients with advanced melanoma who were given MK-3475 every two to three weeks. Confirmed response (reported in the NEJM) to the treatment was found in 38 percent of patients. START is based in San Antonio, with clinic sites in Madrid and Shanghai, and operates the world's largest Phase I pro - gram for new anticancer agents. Merck's release on the news is located at: www. mul tivu.com/players/English/7248751- merck-keytruda-fda-approval-melanoma. Melanoma is the most serious form of skin cancer and is the 19th most common cause of cancer death in Europe. In 2012, there were an estimated 22,200 deaths from malignant melanoma in Europe. There were an estimated 232,000 new cases of melanoma diagnosed worldwide in 2012. Pembrolizumab (MK-3475) is an investi - gational, selective, humanized, monoclonal anti-PD-1 antibody designed to reactivate anti-tumor immunity. Pembrolizumab ex - erts dual ligand blockade of the PD-1 path- way by inhibiting the interaction of PD-1 on T cells with its ligands PD-L1 and PD-L2. With centers located in Madrid, Shanghai, and San Antonio, START oper - ates the largest global, 24-hour Phase I research organization. START's mission M D N E W S . CO M ■ MD NEWS San Antonio | 1 7

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