In The Know: Can new therapies challenge Keytruda’s dominance amongst non-small-cell lung cancer treatments?

The combination of Opdivo (nivolumab) and Yervoy (ipilimumab) from Bristol-Myers Squibb  stands to grab as much as 10% of market share among first-line non-small-cell lung cancer (NSCLC) therapies, according to Howard West, Associate Clinical Professor of medical oncology and therapeutics research at the City of Hope Comprehensive Cancer Center, Duarte, CA, US. This is despite the fact that Merck & Co.’s Keytruda (pembrolizumab) has emerged as the leader in the first-line treatment of non-driver mutated metastatic NSCLC.

“Opdivo/Yervoy is likely to be the strongest challenger [to Keytruda] for the next couple years,” he said, adding “it obviously has to get FDA-approved first, but will need to get used more broadly by community oncologists without them getting overwhelmed by toxicity concerns.”

What happened?

West was just one of 12 of the world’s foremost key opinion leaders (KOLs) from the US and the EU who weighed in on the likelihood that new therapy options would be adopted to treat NSCLC in the latest KOL Insight report.

The bigger picture

The KOLs compared clinical data and adoption outlooks across 10 marketed brands to treat NSCLC, as well as 10 pipeline programmes. While some therapies hold promise, particularly in specific settings, Keytruda came out on top in metastatic, non-driver mutated disease. The well-known brand holds 80% to 90% of market share according to West, and no other therapies have come close to challenging its dominance, given the treatment’s compelling long-term survival data. Compared to the current five-year survival rate of less than 18% for NSCLC patients, Keytruda’s recent 23.2% survival rate presented at this year’s American Society of Clinical Oncology (ASCO) annual meeting was especially encouraging.

“It was reassuring to see that the tail remained relatively flat over time,” one KOL said, adding “it was inspirational for those of us who have been treating lung cancer for a while to be able to know a statistic like that, which would have seemed crazy just five or 10 years ago.”

The KOLs pinpoint further opportunities for Keytruda earlier in the treatment algorithm, for example in adjuvant and neoadjuvant settings.

“Some of the early trials of immuno-chemo combinations in the neoadjuvant setting looking at pathological complete response have been overwhelming,” one KOL said, adding “pembrolizumab and chemotherapy has a huge potential benefit. This could make huge changes.”

As Keytruda’s star has risen, Opdivo has become less prevalent as a treatment option. While it has generally been used in the second-line metastatic setting, KOLs saw its use declining, and expressed mixed opinions on whether it would catch on when used in conjunction with Yervoy. The main concern is the toxicity associated with the latter.

“It’s beleaguered,” one KOL said, adding “I think it will have a role and some positive data, but the toxicity and the positivity are not going to compare well to pembrolizumab regimens. I think it will just be a niche 4% market use kind of combination.”

The one bright spot for Opdivo is its potential application in neoadjuvant settings. If Bristol-Myers Squibb sees positive results out of its Phase III trial, the therapy could remain a contender in this space. While some KOLs still expressed reservations, others were cautiously optimistic.

“I feel the future is not going to be chemotherapy, even though we have pretty good results, but rather nivolumab and ipilimumab because of the reduced side effects,” one KOL said, adding “the addition of ipilimumab may potentially increase survival like we see in melanoma. So I feel good about this and it’s a Phase III trial that I will watch out for.”

Tecentriq and Imfinzi may also find small niches in the market, particularly for non-resectable early-stage NSCLC, as well as in patients that do not respond or lose their response to Keytruda.

Final thoughts

While Keytruda is the main headline in driver mutation-negative NSCLC, there’s an entirely different armamentarium of treatments for driver mutation-positive disease, with a number of players jockeying for market share, including Tagrisso, Alecensa, Xalkori and Rozlytrek.

KOLs were mixed on how the market might shift going forward, but all will be watching the results of upcoming neoadjuvant studies closely to see if Keytruda will continue to dominate the market, and maybe present a brighter future for NSCLC patients.

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