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Imdelltra extended median survival by over 5 months

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27% of Imdelltra patients had serious side effects vs 62%

of

chemotherapy patients

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Trial results intended to back up the drug's accelerated

approval

By Deena Beasley

June 2 (Reuters) - Amgen's ( AMGN ) Imdelltra reduced

the risk of death by 40% compared to chemotherapy for small cell

lung cancer patients whose disease had worsened after an initial

round of chemo, according to interim data from a late-stage

trial presented at a major medical meeting on Monday.

The Phase 3 trial of 509 patients showed that Imdelltra

extended median overall survival by more than five months to

13.6 months, compared with 8.3 months for standard-of-care

chemotherapy, the company said.

The median length of time patients lived without their

disease worsening, a measure known as progression-free survival,

was 4.2 months for the Imdelltra group and 3.7 months for

patients who received chemotherapy.

Amgen ( AMGN ) said the trial results are intended to serve as

confirmatory evidence to support last year's accelerated

approval by the U.S. Food and Drug Administration of Imdelltra

for patients with extensive stage small cell lung cancer whose

disease worsened on or after platinum-based chemotherapy.

The findings were presented at the American Society of

Clinical Oncology's annual meeting in Chicago and published in

The New England Journal of Medicine.

Most lung cancer cases are non-small cell, while up to 15%

are the more aggressive small cell variety targeted by

Imdelltra, according to the American Cancer Society.

The Amgen ( AMGN ) drug belongs to a class of treatments called

bispecific antibodies designed to attach to a cancer cell and an

immune cell, bringing them together so that the body's immune

system can kill the cancer.

Amgen ( AMGN ) said 27% of trial patients treated with Imdelltra

experienced serious side effects, including low white blood cell

counts, compared with 62% of chemotherapy patients. Patients on

Imdelltra reported improvements in cough and shortness of breath

compared to the chemotherapy group.

Cytokine release syndrome, a potentially dangerous condition

that occurs when the body's immune system responds over

aggressively to infection or immunotherapy drugs, was primarily

low-grade and manageable, Amgen ( AMGN ) said.