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New data presented at the annual meeting of the American Association for Cancer Research (AACR) this past week has further emphasised the paradigm shift in cancer therapy that PD-1 inhibitors offer.
Focusing on the two most advanced products in this class - Bristol-Myers Squibbs Opdivo and Merck & Co.s Keytruda - FirstWord is polling US and EU5-based oncologists this week to gauge opinion towards two specific areas of future usage.
In the melanoma market, where both products are already approved as second-line therapies, Bristol-Myers Squibb demonstrated further evidence that Opdivo, when used in combination with its CTLA-4 inhibitor Yervoy, was significantly more effective than Yervoy alone for first-line therapy. Indeed, the Checkmate-069 study demonstrated that in first-line stage III and stage IV melanoma patients, the combination triggered an objective response rate of 61 percent versus 11 percent for Yervoy monotherapy (ViewPoints: Bristol-Myers Squibb ups the stakes with combination melanoma play).
Retaining a first-line presence for the Yervoy franchise in melanoma will be key in allowing Bristol-Myers Squibb to build a franchise position in this indication and meet consensus revenue forecasts. Nevertheless, increased efficacy comes with a notably increased toxicity profile, with 54 percent of combination-treated patients suffering from grade 3 or 4 adverse reactions versus 17 percent of those patients treated with just Yervoy
Quite how this combination will fit into the treatment paradigm remains to be seen, and we are asking oncologists to estimate (based on the Phase II data)
- What percentage of first-line patients they would anticipate being treated initially with the combination of Opdivo and Yervoy?
What percentage of first-line patients they would expect to be initially treated with a more flexible regimen, such as Opdivo with subsequent addition of Yervoy if necessary?
- What impact they expect the side-effect profile for the combination of Opdivo and Yervoy to have in limiting use of this combination in the first-line setting?
Switching focus to the second-line treatment of non-small-cell lung cancer, Bristol-Myers Squibb and Merck both continue to demonstrate impressive manoeuvrability in moving Opdivo and Keytruda, respectively, faster to market than expected. With Bristol-Myers Squibbs Checkmate-057 stopped early, Opdivo has now demonstrated survival benefit in both squamous and non-squamous patients, while Keytruda has been filed as a second-line therapy on the strength of data from the Keynote-001 study, Merck confirmed last week (ViewPoints: Merck & Co. ups its game again, but Bristol-Myers Squibb takes lead in NSCLC PD-1 race).
Notably, the FDA has confirmed that it will not require overall survival data for Keytruda prior to approval, which appears to not only remove any overhang that Opdivo could quickly raise barriers to entry in the lung cancer indication, but confirm that Merck - to some extent - will continue to piggy-back on Bristol-Myers Squibbs first-to-market status. A key question is whether this extend to labelling and usage of Keytruda, given that the Keynote-001 study stratified patients by PD-L1 biomarker status (while Opdivo - in the second-line setting at least - has been studied in all comers).
On this issue, we are asking oncologists
- To provide their assessment of available data to ascertain whether either Opdivo or Keytruda is more strongly positioned in the second-line NSCLC market?
- Whether initial usage of Keytruda will occur in all second-line NSCLC patients or just PD-L1 over expressers, and how labelling and or study design may dictate this?
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