Physician Views: FirstWord is polling oncologists about the potential impact of Opdivo's failed Checkmate-026 study in first-line lung cancer

Bristol-Myers Squibb delivered a major shock last week by confirming that its PD-1 inhibitor Opdivo failed to demonstrate progression-free survival (PFS) or overall survival (OS) benefit in first-line non-small-cell lung cancer patients. An aggressive trial design for the Checkmate-026 study – in particular a low 'cut-off' point when defining PD-L1 expression – appears to be the culprit for this failure.

The implications could be far-reaching, but in the short term will primarily impact Merck & Co.'s competing PD-1 inhibitor Keytruda. Utilising a study design with a higher PD-L1 expression cut off (>50 percent PD-L1+ versus the >5 percent PD-L1+ used in Checkmate-026), Merck's Keynote-024 study demonstrated both a PFS and OS benefit in favour of Keytruda versus chemotherapy in first-line NSCLC patients, the company announced earlier this year.

The upshot is potential early dominance of the first-line opportunity by Keytruda; a segment of the market that analysts had expected Opdivo to dominate given its strong penetration of the second-line setting. In addition, analysts have been quick to speculate that Keytruda may benefit from a 'halo' effect in second- and third-line patients, while it remains to be seen how oncologists construe failure of Opdivo in the Checkmate-026 study.

To better understand the immediate implications stemming from Opdivo's failure in Checkmate-026, FirstWord's latest Physician Views poll is asking US and EU5-based oncologists the following questions…

Assuming Keytruda gains approval for the treatment of first-line NSCLC patients with >50 percent PD-L1+, how quickly do you expect adoption to occur in this population?

None

Slowly

Moderately

Quickly

Very quickly

Following approval would you anticipate any off-label use of Keytruda in lower-expressing first-line patients or will Opdivo's failure to achieve PFS/OS endpoints in a broader population limit this?

None

Marginal use

Moderate use

Significant use

Very significant use

Given the respective top-line results for Keytruda and Opdivo in first-line patients, do you expect this to have a positive impact on the use of Keytruda in second- and third-line patients? (note: Keytruda is pending approval for second-line NSCLC in EU)

No

Marginal impact

Moderate impact

Significant impact

Very significant impact

Has your perception of Opdivo (i.e. as a second-line treatment for NSCLC per its label) changed materially following its failure to demonstrate PFS or OS benefit in first-line NSCLC patients with >5 percent PD-L1+?

No – perception the same

Yes – marginally

Yes – moderately

Yes – significantly

Yes – very significantly

Will the failure of Opdivo to demonstrate a PFS/OS benefit in a broader first-line patient population make you more likely to test second-line patients for PD-L1 status prior to treatment with a PD-1 inhibitor (Opdivo or Keytruda)?

No

Yes

Results and related analysis will be published for FirstWord Pharma PLUS subscribers to read, with the opportunity for non-FirstWord Pharma PLUS subscribers to purchase these findings. To be notified when poll results and analysis become available, please click here.

As always, FirstWord would very much like to receive your feedback and suggestions. Note: FirstWord Polls are powered by MedePolls, a fast-turnaround service to conduct instant polls of up to five questions with guaranteed samples that include physicians from dozens of specialties and over 100 markets. To conduct this poll with a different audience, or an entirely different poll, contact us at info@firstwordpharma.com 

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