Complexity is the operative word in Pharm Exec’s 2017 Pipeline Report. Complex diseases are driving the development of new and innovative therapies while the market adjusts to manufacturing challenges and increasing drug costs.
We’ve recapped some of the main topics in the report, including CAR-T therapies, combination treatments and nonalcoholic steatohepatitis (NASH), among others.
A Winner of the CAR-T Therapy Race?
With an impressive 76% objective response rate and 47% complete remissions in its ZUMA-1 trial in diffuse large B cell lymphoma (DLBCL), Kite Pharma is well-positioned to bring the first CAR-T therapy to market sometime in 2017.
While the interim study results are impressive, the final decision rests with the FDA, who may want to see more prolonged results. Juno Therapeutics is also a contender in the CAR-T therapy race, with an expected market entry in 2018.
Trending: Combination Therapies
To match the continual discovery of new complexities in cancer, developers are working to combine immune-oncology (IO) therapies with traditional therapies, chemotherapy, CAR-T therapies, and other IO therapies to find the best pairings.
Some combinations currently being tested include Durvalumab and TPIV 200; TG4001 and avelumab; Keytruda and Ramucirumab; KTE-C19 and Tecentriq; and JCAR014 and Durvalumab.
The Next Big Focus in Drug Development?
Nonalcoholic steatohepatitis (NASH) is getting a lot of attention as the next major focus for monotherapy and cocktail drug development in biopharma. An estimated 2–5% of Americans are affected by NASH and exhibit cirrhosis or liver failure despite consuming little or no alcohol. NASH treatments could also have an impact in the obesity market down the road.
Several NASH drugs are being developed including cenicriviroc (Allergan/Tobira), AKN-083 (Allergan/Akarna), simtuzumab (Gilead), GS-4997 (Gilead), Ocaliva (Intercept), elafibranor (Genfit), and GR-MD-02 (Galectin).
Read the full 2017 Pipeline Report. for projections, trends and developments in more areas, including targeted therapy, Alzheimer’s disease, the Zika virus, and ophthalmology treatments.