Yescarta Shows Long-Term Success for NHL

The analysis demonstrated that after a median follow-up of more than five years, patients treated with Yescarta continued to experience durable response and long-term survival. The data were shared in an oral presentation (Abstract #864) during the 66th American Society of Hematology (ASH) Annual Meeting and Exposition.

In ZUMA-5, 159 patients were enrolled (127 FL, 31 MZL, 1 DLBCL [later excluded]). At a median follow-up of 64.6 months (range, 32.3-81.4; FL: 65.7, MZL: 55.8), the overall response rate (ORR) was 90% and the complete response (CR) was 75%. Among patients who achieved a CR, 58% remained in CR at the time of data cutoff. The median duration of response (DOR) was 60.4 months (95% CI, 39.7-not estimable [NE]; FL: 60.4, MZL: not reached [NR]), with estimated 60-month DOR of 53.4% (95% CI, 43.9-62.0; FL: 52.2%, MZL: 60.0%). Median progression-free survival (PFS) was 62.2 months (95% CI, 34.9-NE; FL: 57.3, MZL: NR). PFS rates at 60 months in patients with FL were consistent regardless of high-risk characteristics.

Median time to next therapy was NR in all patients with NHL (95% CI, 38.6-NE; consistent by disease type), with a 60-month estimated rate of 53.3% (95% CI, 45.0-60.9; FL: 54.0%, MZL: 50.9%). At data cutoff, 55% of patients (n=87) were alive with no new anticancer therapy. The median overall survival (OS) was NR (95% CI, NE-NE; consistent by disease type), and the 60-month OS estimate was 69.0% (95% CI, 60.8-75.8; FL: 68.9, MZL: 71.1).

No new Yescarta-related safety signals emerged in the five-year analysis. One patient progressed after the data cutoff of the four-year analysis and no patients died of disease progression after the prior analysis. Among treated patients (n=152, 124 FL, 28 MZL), three new events not related to Yescarta were reported after the four-year analysis, including Grade 3 metastasis, Grade 1 bladder cancer, and Grade 4 myelodysplastic syndrome (a serious adverse event). One patient died of pneumonia, unrelated to Yescarta. At any time on trial, a total of 46 patients died, due to progressive disease (n=14), secondary malignancies (n=6), infections (n=11), or another or unknown cause (n=15).

" There is growing evidence that people with follicular lymphoma and marginal zone lymphoma can experience long-term survival after one Yescarta treatment,” said Dominique Tonelli, VP, Global Head of Medical Affairs, Kite. “With no lymphoma-specific events in the five-year follow-up of ZUMA-5 patients, Yescarta may offer patients the chance to live longer without need for subsequent therapy and a potential cure.”

" Relapsed or refractory non-Hodgkin lymphomas, including follicular lymphoma and marginal zone lymphoma, are generally considered to be incurable, with most patients ultimately relapsing,” said Dr. Sattva S. Neelapu, lead investigator, The University of Texas MD Anderson Cancer Center. “These impressive results demonstrate the continued durable clinical benefit and manageable long-term safety profile of axi-cel and give us hope that it may have a curative effect on these difficult-to-treat blood cancers.”