Pembrolizumab +/- V940

This trial is currently recruiting at the CHUM and MUHC.

Despite the fact that most of our patients currently have neoadjuvant IO-CT, there’s still a subset that turn out to be upstaged post surgery and therefore require adjuvant therapy.

I would not refer my patients if they had EGFR mutation, ALK rearrangement or PDL1<1%.

Even NCCN guidelines mention that: « The benefit for Pembrolizumab in patients with PD-L1 <1% is unclear »

In practice I am only refering patients who are EGFR neg, ALK neg and PDL-1 1-49%.

For patients with PD-L1 > 50%, it’s worth discussing this trial, although personally I would be uncomfortable if my patient falls in the standard arm, with the OS data of IMPOWER-010 and the weird data of PEARL.

FDA already granted Breakthrough Designation Therapy for this combination in high risk melanoma based on the Phase II Keynote-942 trial.

mRNA-4157/V940 is a novel investigational messenger ribonucleic acid (mRNA)-based personalized cancer vaccine made of a single synthetic mRNA coding for up to 34 neoantigens.

The vaccine works by stimulating an immune response through generating specific T cell responses based on the unique mutational signature of a patient’s tumor.