NSCLC disrupted

How companies are changing NSCLC plans based on ASCO data

This year’s ASCO made clear that PD-1 inhibitors have supplanted chemotherapy as standard of care in first-line metastatic NSCLC. The unanticipated consequence is the knock-on effects for companies with studies under way in both first- and later-line use.

At least two lessons are apparent: it will become increasingly difficult to perform later-line metastatic non-small cell lung cancer (NSCLC) trials in PD-1 naïve patients, and first-line studies will have to use an approved anti-PD-1 therapy as the comparator.

Data presented at this year’s meeting of the American Society of Clinical Oncology (ASCO) suggest that few companies have awoken to this reality.

For example, at least three programs presented at ASCO in second- or third-line disease excluded patients who had received prior PD-1 or PD-L1 therapies.

Traditionally, it has taken more than five years for companies to move a novel agent from the last-line or salvage setting up to first-line treatment, giving competitors time to adapt their programs.

But Merck & Co. Inc.’s Keytruda pembrolizumab made the leap in less than 18 months, receiving its first approval for metastatic second-line NSCLC in October 2015, and first-line approvals in October 2016 and May 2017, for different PD-L1 expression levels.

“It’s amazing how fast the field has moved and caused this to happen. The time frame got compressed and now people who were thinking that they had time, have lost it,” said Jill O’Donnell-Tormey, CEO and director of scientific affairs for the Cancer Research Institute (CRI).

Metastatic NSCLC trials started in the last two years in first-, second- or third-line settings will need to salvage some purpose or face obsolescence.

“All of what we’ve done for I-O naïve populations in later settings, those results are now irrelevant,” said Karen Reckamp, co-director of the Lung Cancer and Thoracic Oncology Program at City of Hope.

“The time frame got compressed and now people who were thinking that they had time, have lost it.”

Jill O’Donnell-Tormey, Cancer Research Institute

Companies that fail to change enrollment criteria will likely face increased enrollment times or find it impossible to recruit patients. And trials intended for first-line use

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