Pembrolizumab plus chemo shows prolonged OS and PFS improvement vs chemo for squamous NSCLC

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Published: 11 Sep 2022
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Dr Silvia Novello - University of Turin, Turin, Italy

Dr Silvia Novella speaks to ecancer about the 5 year outcomes of the phase 3 KEYNOTE-407 study into pembrolizumab plus chemotherapy in squamous non-small cell lung cancer (NSCLC).

Pembrolizumab + platinum-based chemotherapy significantly prolonged OS and PFS compared with placebo + chemotherapy in patients with previously untreated, metastatic squamous NSCLC in the phase III KEYNOTE-407 study. 

After 5 years of follow-up, pembrolizumab + chemotherapy continued to demonstrate prolonged OS and PFS vs chemotherapy alone without increased toxicity. Most patients who completed 35 cycles had objective responses and were alive at data cutoff. 

The long-term data supports use of pembrolizumab + chemotherapy as a standard first-line treatment option for metastatic squamous NSCLC.

The 407 randomised phase III trial already demonstrated an advantage in terms of overall survival
and progression free survival for pembrolizumab plus chemotherapy versus placebo plus
chemotherapy in untreated squamous advanced non-small cell lung cancer. During this meeting we
got the presentation on the five-year follow-up data, so long-term follow-up data. We saw a
confirmation of the advantage of pembrolizumab plus chemo in this group of patients.

What data has been presented previously and what updates are there?

What we have seen before is the publication in JTO in 2020 with a follow-up of around 15 months and
an advantage in terms of OS with a hazard ratio of 0.71. During this meeting the follow-up time is near
to five years and there is still an advantage for pembrolizumab plus chemo even if the crossover of
the patients is around 51%. That means that those patients in pembrolizumab plus chemo crossed on
study and out of the study to receive pembrolizumab. Despite this high percentage, the difference in
terms of overall survival is still there and the hazard ratio is 0.71.

Another important thing is the five year overall survival data. We have quite a doubled rate in the
pembrolizumab plus chemo arm versus those treated with placebo plus chemo. One further data that
I would like to underline is regarding those patients who received 35 cycles of pembrolizumab, so a
long treatment with mono-immunotherapy. For those patients there is a higher response rate and a
higher three-year overall survival time. Those are patients in which we have maybe to invest more
and to know more also from a research point of view.

Are there any adverse event updates?

No safety issue or, let’s say, no news about the safety compared to the data that we already know
from 407. Also for those patients receiving a long-term mono-IO no safety issue and no news, mainly
about the immune related adverse events no difference from what we already know from this
combination.

How will this impact future treatment options?

I believe that this is a confirmation of what we know, that is in the patients with advanced squamous
non-small cell lung cancer, the treatment and the standard of care is the combination of
pembrolizumab plus chemotherapy, regardless of the PD-L1 expression.