Nivolumab (Opdivo) plus ipilimumab (Yervoy) in combination with two cycles of platinum-doublet chemotherapy has been added to the PBS for patients with previously untreated squamous stage IV non-small cell lung cancer (NSCLC) who are EGFR and ALK negative.
The PBS listing is supported by evidence including the recently published CheckMate 9LA study which found the combination of NIVO+IPI+platinum was more efficacious compared to chemotherapy alone.
In its November 2020 recommendation for PBS listing of the combination, the PBAC said NIVO+IPI+platinum was not expected to provide a substantial or clinically relevant improvement in efficacy, or reduction of toxicity over pembrolizumab+platinum for squamous NSCLC.
However NIVO+IPI+platinum may provide some patients with a treatment option with less cycles of chemotherapy.
“The PBAC noted there are less treatment options for patients with squamous NSCLC and considered an additional treatment option may be useful for some patients.”
“The PBAC noted that consumers valued additional treatment options, even if there was no difference in clinical outcomes,” the Public Summary Document from the meeting said.
Medical oncologist Associate Professor Tom John, from the Peter MacCallum Cancer Centre, told the limbic that the PBS listing was providing another valuable treatment option.
“So there is another very good option – and that’s chemotherapy combined with pembrolizumab. That’s our current standard of care.”
He said the pembrolizumab regimen uses four cycles of chemotherapy combined with Keytruda for as long as it works.
“That’s quite effective but we know that patients with squamous cell cancer don’t do as well in general so having options is great. I guess the tough call is when to use this [new] regimen because we do have something that is pretty good already.”
He said the combinations of chemo and immunotherapy appeared to be similar.
“As always with these studies there is no direct comparison between these two regimens but cross-trial comparisons show both regimens do reasonably well. But this new regimen seems to do better in low PD-L1 and people who were previously heavy smokers.”
“That’s where I think this regimen fits in – especially if the patients are young and fit.”
He said while the advantage of the NIVO+IPI+platinum was only two cycles of chemo not four, it involved more immunotherapy which has its own potential immune-related toxicities.
Federal Health Minister Greg Hunt said without the listing patients would otherwise pay over $100,000 per course of treatment.
The November 2020 PBAC meeting did not recommend NIVO+IPI+platinum for the treatment of previously untreated stage IV non-squamous NSCLC.