August 22, 2017
By Mark Terry, BioSpace.com Breaking News Staff
Biopharma companies have done a pretty good job in recent years at developing new and effective approaches to treating cancer. First to come to mind is the entire field of immuno-oncology (IO), which is turning out to be revolutionary in many ways. Market research company EvaluatePharma analyzed the late-stage cancer drugs and the companies developing them, and projected worldwide sales five years from now if they should be approved. Keith Speights, writing for The Motley Fool, takes a look.
1. Eli Lilly and abemaciclib.
Abemaciclib (LY2835219) is a selective ATP-competitive inhibitor of CDK4 and CDK6 kinase activity, which are activated in many tumors. The compound is being evaluated in clinical trials in breast cancer, non-small cell lung cancer, and pancreatic cancer, as well as in a combination trial in immuno-oncology.
EvaluatePharma projects, if approved, abemaciclib could create sales of $1.8 billion by 2022. The drug was given a priority review status by the U.S. Food and Drug Administration (FDA) in July for advanced breast cancer, so approval could roll around in early 2018. The company also plans to submit for approval in Europe by the end of the third quarter this year and in Japan by the end of 2017.
Speights writes, “In a late-stage study of abemaciclib in combination with AstraZeneca (AZN)’s 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. Incyte Corporation and epacadostat.
Epacadostat is being evaluated in eight clinical trials for various cancers, including non-small-cell lung cancer, renal cancer, head and neck cancer, and bladder cancer. The one to watch is a Phase III trial of the drug in combination with Merck (MRK)’s Keytruda in melanoma. At the American Society of Clinical Oncology (ASCO) meeting held in June, Incyte reported interim data on the trial, which was very promising. The total response rate for the combination was 35 percent, compared to monotherapy data of 18 percent for Keytruda and 20 percent for Bristol-Myers Squibb (BMY)’s Opdivo. And it’s possible that response rate will improve as the study progresses.
If approved, EvaluatePharma projects the drug could rake in over $1.7 billion in sales in 2022.
3. Johnson & Johnson and apalutamide.
Apalutamide (ARN-509) is being evaluated for pre-metastatic prostate cancer. It is in several different Phase III clinical trials for varying types of prostate cancer. The SPARTAN trial is for men with non-metastatic, castration-resistant prostate cancer. The ATLAS trial is for men with high-risk localized and locally advanced prostate cancer in combination with radiation therapy. And another trial, NCT02257736 is evaluating men with chemotherapy-naïve, metastatic, castration-resistant prostate cancer in combination with abiraterone acetate and prednisone.
EvaluatePharma projects the drug, if approved, could bring in annual sales of $1.6 billion five years from now. The company expects to make its first regulatory filing in the first half of next year with possibly three more by 2021.
All of these look promising, but Speights is quick to note that in drug development, things can and often do go wrong. He writes, “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.”
Still, if approved, they’ll be of great benefit to the companies and their patients.
