FDA News

FDA grants breakthrough therapy designation to Imfinzi for non-small cell lung cancer

The FDA granted breakthrough therapy designation to durvalumab for the treatment of locally advanced, unresectable non-small cell lung cancer, according to the drug’s manufacturer.

The agency based the designation on interim results of the randomized phase 3 PACIFIC trial. The double-blind, placebo-controlled, multicenter study evaluated durvalumab (Imfinzi; AstraZeneca, MedImmune) — a human monoclonal antibody directed against PD-L1 — as a sequential treatment for patients with locally advanced, unresectable NSCLC whose disease had not progressed after standard platinum-based chemotherapy with adjuvant radiation therapy.

PFS and OS served as the primary endpoints. Secondary endpoints included landmark PFS and OS, objective response rate and duration of response.

“For patients who have not progressed following chemoradiation therapy, the only current option is active monitoring,” Sean Bohen, executive vice president of global medicines development and chief medical officer at AstraZeneca, said in a company-issued press release.

“Unfortunately, for the majority of patients, their cancer will progress to metastatic disease, typically within 12 months. Imfinzi is the first immuno-oncology medicine to show a clinically significant benefit in this earlier, nonmetastatic setting so, following the breakthrough designation, we hope to bring it to patients as soon as possible.”

Durvalumab is being investigated for the treatment of NSCLC in multiple ongoing studies, including:

  • the phase 3 ADJUVANT trial, designed to evaluate durvalumab in the adjuvant NSCLC setting;
  • the phase 3 MYSTIC, NEPTUNE and PEARL trials, designed to evaluate durvalumab as monotherapy and in combination with tremelimumab (MedImmune) as frontline treatment for patients with stage IV NSCLC; and
  • the POSEIDON trial, designed to evaluate durvalumab with and without tremelimumab in combination with chemotherapy.

The FDA granted breakthrough therapy designation to durvalumab for the treatment of locally advanced, unresectable non-small cell lung cancer, according to the drug’s manufacturer.

The agency based the designation on interim results of the randomized phase 3 PACIFIC trial. The double-blind, placebo-controlled, multicenter study evaluated durvalumab (Imfinzi; AstraZeneca, MedImmune) — a human monoclonal antibody directed against PD-L1 — as a sequential treatment for patients with locally advanced, unresectable NSCLC whose disease had not progressed after standard platinum-based chemotherapy with adjuvant radiation therapy.

PFS and OS served as the primary endpoints. Secondary endpoints included landmark PFS and OS, objective response rate and duration of response.

“For patients who have not progressed following chemoradiation therapy, the only current option is active monitoring,” Sean Bohen, executive vice president of global medicines development and chief medical officer at AstraZeneca, said in a company-issued press release.

“Unfortunately, for the majority of patients, their cancer will progress to metastatic disease, typically within 12 months. Imfinzi is the first immuno-oncology medicine to show a clinically significant benefit in this earlier, nonmetastatic setting so, following the breakthrough designation, we hope to bring it to patients as soon as possible.”

Durvalumab is being investigated for the treatment of NSCLC in multiple ongoing studies, including:

  • the phase 3 ADJUVANT trial, designed to evaluate durvalumab in the adjuvant NSCLC setting;
  • the phase 3 MYSTIC, NEPTUNE and PEARL trials, designed to evaluate durvalumab as monotherapy and in combination with tremelimumab (MedImmune) as frontline treatment for patients with stage IV NSCLC; and
  • the POSEIDON trial, designed to evaluate durvalumab with and without tremelimumab in combination with chemotherapy.

    See more from Immuno-Oncology Resource Center