Zepzelca, Tecentriq combo extends survival in hard-to-treat lung cancer

A combination of Roche’s cancer immunotherapy Tecentriq and a drug called Zepzelca helped extend survival in people with a hard-to-treat form of lung cancer, according to clinical trial data made public Thursday.

The Phase 3 trial enrolled 660 people with small cell lung cancer that has metastasized, and sought to show that using Tecentriq and Zepzelca in combination as maintenance therapy could delay progression and death better than Tecentriq alone. The trial’s results are set to be presented at the American Society of Clinical Oncology’s annual meeting on June 2.

The Food and Drug Administration has approved four cycles of Tecentriq plus chemo as a first-line therapy, after which Tecentriq is used alone as maintenance. In testing supporting that clearance, the Tecentriq-based regimen helped people live a median of 12.3 months, two months longer than chemo alone, and kept their disease from progressing for 5.2 months, less than a month longer than chemo.

Maintenance therapy is used to delay the return of cancer or to stabilize disease once an initial round of treatment has helped control a patient’s tumor.

In the Roche-sponsored trial with Zepzelca, 483 participants were eligible to move on to the maintenance stage following initial treatment with chemo and Tecentriq. Among those who did, progression-free survival reached a median of 5.4 months for people given Tecentriq and Zepzelca, compared to 2.1 months in the Tecentriq-only group. Median overall survival was 13.2 months and 10.6 months, respectively.

Side effects were higher in the combination arm, though, affecting 84% of patients compared to 40% receiving only Tecentriq. Severe side effects were also higher. Two patients receiving the combination died, from sepsis and febrile neutropenia, respectively, while one patient on Tecentriq alone died from sepsis.

The FDA gave conditional approval to Zepzelca in 2020 to treat people whose small cell lung cancer has progressed. The clearance was based on tumor response rates and treatment duration, so it still needs to be confirmed in a trial that compares Zepzelca to another treatment regimen.

“We would anticipate that it would be moved into the first-line maintenance setting,” said Julie Gralow, ASCO’s chief medical officer, on a Wednesday call with reporters. “Progression-free survival is still quite low in both arms, and we need to work on additional ways of advancing this even further.”

“So it is a small next step,” she added.

Zepzelca was developed by the Spanish biotech PharmaMar, which has made human medicines from chemicals identified in marine organisms. Zepzelca is a synthetic version of a compound found in a type of marine invertebrate called a colonial ascidian.

Jazz Pharmaceuticals licensed U.S. rights to Zepzelca in 2019, and later added marketing rights in Canada. Jazz reported Zepzelca sales of $320 million last year and paid PharmaMar royalties of 56 million euros, or about $60 million.

Jazz recently submitted an approval application to the FDA for Zepzelca’s use as maintenance therapy based on the data that will be presented at ASCO.

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