Progress marches on in the fight against cancer. While more biosimilars are becoming available for top cancer drugs of the past, biopharmaceutical companies are developing newer and more powerful treatments.
Market research firm EvaluatePharma evaluated all of the experimental cancer drugs in late-stage development. The firm ranked these drugs by projected worldwide sales five years from now -- assuming the drugs win regulatory approval. Eli Lilly (LLY -2.63%), Incyte (INCY -0.89%), and Johnson & Johnson (JNJ 1.49%) each landed a top spot in that ranking for their pipeline candidates. Here are the three most promising cancer drugs in late-stage development.
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1. Abemaciclib
Eli Lilly could have a big winner on its hands with abemaciclib. EvaluatePharma projects the drug will generate sales of $1.8 billion by 2022, if approved. The U.S. Food and Drug Administration (FDA) granted priority review for abemaciclib in July as a treatment for advanced breast cancer, which means that an approval decision should be made in early 2018. Lilly also plans to file for regulatory approval in Europe by the end of the third quarter of 2017 and in Japan by the end of the year.
In a late-stage study of abemaciclib in combination with AstraZeneca's (AZN 0.28%) Faslodex, breast cancer patients receiving the combo therapy achieved median progression-free survival rates of 16.4 months compared to 9.3 months for those receiving Faslodex alone. Abemaciclib also demonstrated improvement in progression-free survival rates for breast cancer patients in a late-stage study with the drug combined with either letrozole or anastrozole chemotherapies.
2. Epacadostat
Incyte's epacadostat could make over $1.7 billion in sales in 2022, according to EvaluatePharma's analysis. The biotech is evaluating epacadostat in eight clinical studies for treating several types of cancer, including non-small-cell lung cancer, renal cancer, head and neck cancer, and bladder cancer.
The most advanced clinical trial, though, is a late-stage study of epacadostat in combination with Merck's Keytruda targeting treatment of melanoma. Results from this study are expected in 2018. Incyte also plans to initiate two other late-stage studies of epacadostat this year, one in combination with Keytruda and another in combination with Bristol-Myers Squibb's Opdivo.
3. Apalutamide
Johnson & Johnson's Imbruvica is projected to rank among the top cancer drugs in the world by 2022. It could be joined by another blockbuster -- apalutamide. The late-stage candidate is projected to pull in sales of $1.6 billion five years from now.
Apalutamide is in four late-stage clinical studies targeting prostate cancer. One of those studies features a combination of the drug with J&J's already-approved prostate cancer drug Zytiga. Johnson & Johnson expects its first regulatory filing will be made by the first half of 2018, with potentially three other submissions by 2021.
Projecting can be a tricky business
It should be noted that making projections for five years in the future isn't a science. Projections can be -- and often are -- way off.
As a case in point, EvaluatePharma picked Astrazeneca's tremelimumab as its No. 4 most promising cancer drug of 2022. However, the firm's rankings were released prior to the British drugmaker's announcement in July of the results from a late-stage study of Imfinzi in combination with tremelimumab in treating lung cancer. The combination therapy failed miserably, raising doubts about whether AstraZeneca's other seven late-stage studies of the two-drug combo would be successful.
All three of the companies that landed experimental drugs in the top three spots have also experienced recent pipeline setbacks. In April, the FDA rejected approval of rheumatoid arthritis drug baricitinib, which was being developed by Lilly and Incyte. Johnson & Johnson also experienced rejection earlier in August when an FDA advisory committee recommended against approval of experimental rheumatoid arthritis drug sirukumab.
Lilly, Incyte, and J&J could be tremendously successful with their promising late-stage cancer drugs. But as Danish scientist Niels Bohr said, "Prediction is very difficult, especially if it's about the future."
