Physician Views: Assessing Keytruda's expanded label in first-line NSCLC

On May 10, the FDA approved Merck & Co.'s PD-1 inhibitor Keytruda in combination with  pemetrexed (Eli Lilly's Alimta) and carboplatin as first-line treatment of patients with metastatic non-squamous non-small-cell lung cancer (NSCLC), irrespective of PD-L1 status. This indication is approved under accelerated approval based on tumor response rate – 55 percent for Keytruda/pemetrexed and carboplatin versus 29 percent for pemetrexed and carboplatin alone - and progression-free survival – 13.0 months versus 8.9 months.

FirstWord is snap-polling US-based oncologists to better understand how utilisation of Keytruda in this setting is likely to evolve. Specifically we are asking them…

The PD-1 inhibitor Keytruda (pembrolizumab) has been approved by the FDA in combination with pemetrexed and carboplatin as first-line treatment of patients with metastatic non-squamous NSCLC, irrespective of PD-L1 status. This indication is approved under accelerated approval based on tumor response rate (55% for Keytruda/pemetrexed and carboplatin versus 29% for pemetrexed and carboplatin alone) and progression-free survival (13.0 months versus 8.9 months). We estimate that around 25 percent of first-line NSCLC patients are treated with pemetrexed and carboplatin. Approximately what percentage of patients with metastatic or advanced non-squamous NSCLC do you think will receive Keytruda plus pemetrexed and carboplatin as frontline therapy?

 

In the short term, do you think lack of overall survival data for the Keytruda/pemetrexed and carboplatin combination will limit utilisation?

No

Yes – slightly

Yes – moderately

Yes – significantly

Yes – very significantly

How comfortable would you be using Keytruda in combination with other chemotherapies as first-line therapy for non-squamous NSCLC?

Not comfortable

Slightly comfortable

Moderately comfortable

Very comfortable

Extremely comfortable 

Although the label does not stipulate a specific cut-off, would you expect to use PD-L1 expression level as a means to determine suitability for treatment with Keytruda plus pemetrexed and carboplatin? (Exploratory analyses for ORR were conducted in subgroups defined by the stratification variable, PD-L1 tumor expression (TPS <1% and TPS ≥1%). In the TPS <1% subgroup the ORR was 57% in the Keytruda-containing arm and 13% in the chemotherapy arm. In the TPS ≥1% subgroup the ORR was 54% in the Keytruda-containing arm and 38% in the chemotherapy arm).

Never

Rarely

Sometimes

Often

Always

Keytruda is also approved as monotherapy in first-line NSCLC patients with PD-L1 expression levels of 50 percent or more. In these patients, Keytruda demonstrated a response rate of 45% (versus 28% for chemotherapy) and median progression-free survival of 10.3 months (versus 6.0 months for chemotherapy). We understand Keytruda monotherapy has gained strong early utilisation in this setting; do you expect approval of Keytruda/chemo combination therapy to reduce use of Keytruda monotherapy in high PD-L1 expressers, based on available data in both settings?

(As a reminder Keytruda/pemetrexed and carboplatin demonstrated a response rate of 55% and progression-free survival of 13.0 months)

No reduction – 'split' in therapeutic option for PD-L1 high expressers and 'all-others' will be distinct

Slight reduction

Moderate reduction

Significant reduction

Very significant reduction  

Results and related analysis will shortly 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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