Full results from the Keynote-024 study of Keytruda (pembrolizumab) in first-line NSCLC (patients with >50% PD-L1 expression) demonstrate median progression-free survival of 10.3 months for Keytruda versus 6 months for chemotherapy (hazard ratio of 50%). Median overall survival data is not yet mature, but at six months 80.2% of Keytruda patients were alive versus 72.2% of chemotherapy patients (hazard ratio of 60%). Twenty-seven (27) percent of Keytruda patients experienced grade 3-5 side-effects versus 53% of chemotherapy patients.
- Once available, how quickly do you expect Keytruda to be adopted as the standard-of-care therapy in first-line NSCLC patients whose tumours express PD-L1 >50%?
- Full results from the CheckMate-026 study show that in first-line NSCLC patients with >1% PD-L1 expression, Opdivo (nivolumab) demonstrated median progression-free survival of 4.2 months versus 5.9 months for chemotherapy. Opdivo also provided no meaningful benefit in tumour progression or survival rates versus chemotherapy in patients with >50% PD-L1 expression.
- Do these data change your current perception of Opdivo’s clinical profile?
- Taking data from the Keynote-024 and CheckMate-026 studies into account, once approved would you expect to use Keytruda monotherapy in first-line patients with <50% PD-L1 expression? Given the respective clinical data for Keytruda and Opdivo in first-line NSCLC patients, do you expect this to have a positive impact on your use of Keytruda in second-line patients? In the Phase III OAK study, Tecentriq (atezolizumab) demonstrated median overall survival (OS) of 13.8 months versus 9.6 months for chemotherapy (hazard ratio of 73%) in second- and third-line NSCLC patients regardless of PD-L1 expression. In patients with >1% PD-L1 expression, Tecentriq demonstrated a median OS of 15.7 months versus 10.3 months for chemotherapy (HR of 74%) and in patients with <1% PD-L1 expression, Tecentriq demonstrated a median OS of 12.6 months versus 8.9 months for chemotherapy (HR of 75%). Patients who already had a strong immune response are reported to have fared even better on the drug, with these subjects living a median of more than 20 months, compared with 8.9 months for chemotherapy.Taking into account that Tecentriq is also dosed once every three weeks (versus every two weeks for Opdivo) how much market share would you expect it to gain at the expense of Opdivo in second-line patients?