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A Key Update on Gilead Sciences’ ZUMA-3 Study

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Gilead’s ZUMA-3 trial

In December 2017, Gilead Sciences (GILD) presented updated results from its ongoing phase-1/2 ZUMA-3 trial. Kite, a Gilead Science company is conducting phase-1/2 ZUMA-3 trial to evaluate the safety and efficacy of KTE-C19, a CD19 chimeric antigen receptor T (or CAR-T) cell therapy for the treatment of adult individuals with relapsed or refractory acute lymphoblastic leukemia (or ALL).

In the ZUMA-3 trial, at a minimum of eight weeks of follow-up, 71% patients who received KTE-C19 single infusion demonstrated complete tumor remission. In the ZUMA-3 trial, patients infused with KTE-C19 did not show detectable minimal residual disease, including patients with high tumor burdens and high-risk genetic abnormalities.

Among the 29 patients under investigation, adverse events showed consistency with the known toxicities of CD19 CAR-T therapy. In the ongoing trial, 28% patients demonstrated grade-3 or higher cytokine release syndrome, while 52% patients showed neurologic toxicities.

Any success in the phase-1/2 clinical trial will likely help Gilead Sciences proceed to the pivotal clinical trials. The success in the clinical trial could also help Gilead Sciences file regulatory filing for commercialization and simultaneously strengthen the company’s product portfolio.

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ALL incidence rate

The National Cancer Institute’s Surveillance, Epidemiology, and End Results Program (or SEER) estimated that there were 5,970 new cases of ALL in the US in 2017. SEER estimated that there were 1,440 deaths due to ALL in 2017 in the US, and studies estimated that ~68.2% of ALL patients survive for five years.

The American Cancer Society estimated that there were 5,960 new cases of ALL and 1,470 deaths due to ALL in the US in 2018.

Some important drugs for ALL include Bristol-Myers Squibb’s Sprycel, Novartis’s (NVS) Kymriah (CAR-T cell therapy) and Gleevec, Takeda Pharmaceuticals’ (TKPYY) Iclusig, and Amgen’s (AMGN) Blincyto.

Remember, the revenue growth of Gilead Sciences’ could boost the share prices the iShares Nasdaq Biotechnology ETF (IBB). Gilead Sciences makes up about 7.9% of IBB’s total portfolio holdings.

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