FDA Gives AstraZeneca’s Imfinzi the Nod for New Lung Cancer Indication

The U.S. Food and Drug Administration (FDA) approved AstraZeneca Pharmaceuticals LP Imfinzi to treat patients with unresectable Stage III non-small cell lung cancer (NSCLC) who had not progressed after platinum-based chemotherapy and radiation.

The approval was based on data from the Phase III PACIFIC trial. It showed an improvement of median progression-free survival (PFS) of 11.2 months compared to placebo, a 48 percent decreased relative risk of progression or death compared to placebo in patients regardless of PD-L1 status.

“The approval of Imfinzi in this earlier stage of non-small cell lung cancer is a truly meaningful milestone for patients who, until now, had no FDA-approved treatment options following chemoradiation therapy,” said Dave Fredrickson, executive vice president, Head of the Oncology Business Unit at AstraZeneca, in a statement. “Globally, approximately 30 percent of patients with NSCLC present with Stage III disease and we are excited to launch the first immunotherapy into this setting.”

Imfinzi (durvalumab) is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80. This prevents the tumors from evading the immune system. The drug has already been approved in the U.S. for patients with locally-advanced or metastatic urothelial carcinoma, who have disease progression during or after platinum-based chemotherapy, or whose cancer has progressed within 12 months of receiving platinum-based chemotherapy before or after surgery.

The drug is also being evaluated for the adjuvant treatment of NSCLC in the Canadian Cancer Trials Group BR31 trial (ADJUVANT), as well as in the MYSTIC, NEPTUNE and PEARL Phase III trials as a first-line treatment as monotherapy or in combination with tremelimumab. It is also being studied in the POSEIDON trial with and without tremelimumab in combination with chemotherapy.

Reuters notes, “Analysts believe using Imfinzi in so-called stage III cancer, where cancer has only spread locally, opens up an annual sales opportunity worth around $2 billion. Importantly, AstraZeneca has a lead of two to three years over other drug companies in this particular area. Deutsche Bank analyst Richard Parkes said the FDA okay came around one month earlier than expected and, together with the recently launched pill Tagrisso, AstraZeneca was now set to add more than $4 billion of high-margin lung cancer sales over the next four years.”

Worldwide, about 30 percent of NSCLC patients are designated stage III. Standard treatment is a combination of chemotherapy and radiation, but approximately 15 percent survive after five years.

The NSCLC market is currently split by products from Bristol-Myers Squibb Company, Roche and Merck & Company, but this expansion approval gives AstraZeneca an entry into that larger market. In addition, combination therapies using Imfinzi have the possibility of expanding their presence even more.

Reuters writes, “Some analysts forecast potential sales of all immunothereapy drugs at as much as $50 billion a year. Still, significant challenges remain, including deciding on optimal treatment regimens for using infused medicines with typical list prices near $150,000 a year.”

Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a statement, “This is the first treatment approved for stage III unresectable non-small cell lung cancer to reduce the risk of the cancer progressing, when the cancer has not worsened after chemoradiation. For patients with stage III lung cancer that cannot be removed surgically, the current approach to prevent progression is chemoradiation. Although a small number of patients may be cured with the chemoradiation, the cancer may eventually progress. Patients now have an approved therapy that has been shown to keep the cancer from progressing for a longer time after chemoradiation.”