Progress continues in opening authorized commercial centers. Gilead remains excited about commercial progress the company has made with Yescarta. The company is on track to meet its goal of expanding the number of authorized centers in the US capable of addressing 80% eligible patients by mid-year, with 40 centers open as of the end of March. Gilead intends to proceed deliberately with its approach, making sure to place significant attention on patient safety, stressing the desire for the experience to be positive.
Gilead believes Yescarta is differentiated in efficacy, commercialization potential. Despite the number of competitors either approved or in late-stage development, Gilead stressed it believes Yescarta is differentiated. Although acknowledging the difficulties of cross-trial comparisons, Gilead noted that its DLBCL trials featured sicker patients with higher resultant ORR and CR rates. In terms of manufacturing time, with the ability to treat larger numbers of patients without bridging therapy, Gilead believes it’s ahead of the competition. Further, the company also cited its growing infrastructure to manufacture CART products, noting the ability to move forward more easily with next-generation therapies, which along with potential “off-the-shelf” products could further increase throughput.
Beyond hematological indications, Gilead interested in solid tumors. In terms of the development stage, Gilead highlighted ZUMA-7 in 2L DLBCL as being particularly important, given the opportunity to replace transplants. Other key trials include ZUMA-2 (mantle cell lymphoma), ZUMA-5 (indolent NHL), and ZUMA-8 (CLL). Longer term, the company is focusing on the prospect of solid tumors, noting its investments to enhance the platform and capabilities, including the recent collaboration with Sangamo and the acquisition Cell Design Labs. These technologies may allow Gilead to be able to control the level of T-cell response or target the T-cell's activity to a specific tissue or organ to reduce toxicities.
Longer term, potential exists to expand platform to non-oncology indications. Even longer term, Gilead speculated that it may be able to expand beyond oncology with its CAR-T platform, including inflammation or immunology, including chronic viral infections like HBV or HIV. However, it stressed that the technology would need to evolve, given the different /benefit profile required with these diseases.