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ASCO conference: Bristol-Myers' Opdivo combo effective in lung cancer trial

Bristol-Myers Squibb Co.'s Opdivo, combined with either a low-dose of Yervoy, or chemotherapy, was more effective than using chemotherapy alone as a first-line treatment for lung cancer, results from a part of a late stage study showed.

According to data from part 1b of the phase 3 CheckMate-227 trial, combining Opdivo, or nivolumab, and chemotherapy helped patients with advanced non-small cell lung cancer live longer without the disease worsening. The patient group comprised those whose tumors have very low levels of PD-L1 protein — a type of protein that plays a major role in suppressing the immune system.

Progression-free survival, or PFS, is the time the patient lived without the disease worsening. It is a secondary endpoint for part 1b of the trial.

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When compared against each other, the one-year PFS rates — percentage of patients who lived for a year without the cancer progressing — were 45% for those taking Opdivo plus Yervoy, 27% for those taking Opdivo and chemotherapy, and 8% for patients just on chemotherapy.

The patient group had high tumor mutational burden, which measures the number of mutations carried by tumor cells. In patients with a low TMB, the one-year PFS rate was 18% for those taking Opdivo and Yervoy, and Opdivo and chemotherapy, while the PFS rate was 16% for patients on chemotherapy.

"Results show Opdivo plus chemotherapy improved progression-free survival versus chemotherapy in first-line lung cancer patients whose tumors do not express PD-L1," said study investigator Hossein Borghaei.

"Taken together with the totality of CheckMate-227 data presented to date, the results reinforce that TMB status provides clinically relevant information for Opdivo-based combinations and that Opdivo plus low-dose Yervoy provided durable efficacy in patients with high TMB," he added.

Treatment-related side effects were observed in 25% of patients who received the Opdivo-Yervoy combination, 52% with Opdivo and chemotherapy, and 35% with chemotherapy alone.

The most common side effects for the Opdivo-Yervoy combination were liver-related, gastrointestinal, endocrine and skin-related reactions. The most common ones for Opdivo-chemotherapy were anemia; neutropenia, or low levels of a type of white blood cells; and fatigue.

Part 1a of the CheckMate-227 study evaluated Opdivo combined with a low dose of Yervoy, or Opdivo alone, versus chemotherapy in patients whose tumors express PD-L1. The part 2 of the trial evaluates Opdivo plus chemotherapy versus chemotherapy, regardless of PD-L1 or TMB status.

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The 2018 American Society of Clinical Oncology meeting is expected to bring together more than 32,000 professionals from all over the world, with more than 2,500 study abstracts to be presented on-site and an additional 3,350 abstracts to be published online.