Christi Shaw, Chief Executive Officer of Kite, said, “With approximately half of the patients with refractory large B-cell lymphoma in our registrational trial alive three years following treatment with Yescarta, we are delivering towards our goal of potentially life-saving therapy for many patients who previously faced limited treatment options and a poor prognosis prior to the introduction of CAR T therapy. These results, coupled with an analysis that suggests a reduced risk of severe CRS and neurological events with earlier use of steroids, further support our ongoing leadership in cell therapy and commitment to patient care.”

Yescarta was the first CAR T cell therapy to be approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy including: diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma and high-grade B-cell lymphoma and DLBCL arising from follicular lymphoma.

By the way, Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma. The Yescarta U.S. Prescribing Information has a BOXED WARNING for the risks of CRS and neurologic toxicities, and Yescarta is approved with a risk evaluation and mitigation strategy (REMS) due to these risks; read on for Important Safety Information.

Updated Results from a Separate ZUMA-1 Safety Management Study

Patients with relapsed or refractory large B-cell lymphoma treated with Yescarta received earlier steroid intervention beginning when patients experienced Grade 1 neurologic events or experienced Grade 1 CRS with no improvement after three days of supportive care. Patients could receive optional bridging chemotherapy prior to Yescarta infusion.

In the analysis 41 patients had received Yescarta, with a median follow-up of 8.7 months; 73% of patients received corticosteroids and 76% received tocilizumab. Earlier steroid use appeared to decrease the percentage of patients with Grade ≥3 CRS (2%) and neurologic events (17%), each of which was numerically lower than rates in the registrational cohorts of ZUMA-1 (13% CRS, 31% neurologic events). There were no Grade 4 or 5 CRS or neurologic events and no Grade 5 AEs related to Yescarta in Cohort 4.

The objective response rate per investigator assessment was 73% in Cohort 4, with 51% of patients achieving a complete response. The median duration of response was 8.9 months. Fifty-four percent of patients in this cohort remained in an ongoing response with at least six months of follow-up after Yescarta infusion. Median OS in Cohort 4 has not been reached.

Prohost Observations

CAR T has started to show its superiority in helping lymphoma patients who do not respond to first-line treatments. Indeed, Gilead CAR T product Yescarta succeeded in extending the life of patients whose cancers either did not respond to previous treatments or would not respond when they recur. Fair analysts and savvy investors recognized the fact that CAR T is a superior approach for cancer treatment but needs work regarding improving its safety and tolerability in addition to enabling it to treat solid tumors.

Gilead’s news is promising and there are currently tremendous efforts being spent to improve the CAR T approach. These efforts are made not only by the firms, which have approved CAR T, but those who are specialized in gene editing such as: Cellectis (CLLS) and Sangamo (SGMO), in addition to other firms which include, Celyad (CYAD) and Atara (ATRA).  

We believe,that the data from ZUMA-1 is positive news for Gilead. Yescarta will begin to boost Gilead’s revenues’ growth, speeding our expected rebounding of the Company’s stock price.

Yes, we believe that the time has come for GILD to outperform.

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