The pipeline of personalized medicines for blood cancers is fit to burst, GlobalData warns.
Branding the development landscape “oversaturated,” the data and analytics company says there are more than 800 cell therapy prospects currently in the hopper for just five major blood cancers. Those cancers are acute lymphocytic leukemia (ALL), B-cell non-Hodgkin lymphoma (B-NHL), acute myeloid leukemia (AML), multiple myeloma and chronic lymphocytic leukemia.
The problem is especially pronounced in ALL, which has more than 300 drugs in the pipeline plus two that already boast FDA approvals, GlobalData points out.
Novartis’ chimeric antigen receptor T-cell (CAR-T) therapy Kymriah won its ALL nod back in 2017. Meanwhile, Gilead Sciences' T-cell immunotherapy Tecartus picked up its ALL indication in October.
“Despite the market size for B-NHL being at least five times the size of ALL, B-NHL has a smaller pipeline of cell therapies,” Sakis Paliouras, Ph.D., managing oncology and hematology analyst at GlobalData, said in a statement. “This means that, given the rarity of the disease, the ALL pipeline is congested,” he said, adding that most ALL CAR-Ts in the pipeline “will never reach the market due to strategic decisions, potentially prioritizing other cancers.”
Gilead’s and Novartis’ success in hematological cancers has ushered in an “abundance” of clinical cell therapy candidates, Paliouras said. The analyst noted that oncology differs from other therapeutic fields such as cardiology or immunology, where it’s typical for there to be “a large number of products with similar attributes.”
“If all of the in-development drugs for blood cancer got the go-ahead from the FDA, competition would be much too fierce,” Paliouras added.
“Me-too” and “late-to-market” drugs will carry a high risk of poor performance, GlobalData notes. The analytics firm also points out that around 80% of the cell therapy pipeline is autologous, despite the “significant advantages” that allogeneic therapies could hold.
Autologous cell therapies are made by modifying a patient’s own cells, while allogeneic therapies utilize cells from healthy donors. Allogeneic cell therapies, also known as "off-the-shelf" treatments, have yet to make it out of the clinic.
All told, the global cell therapy market in oncology is expected to surpass $37 billion by 2028, GlobalData says.
Meanwhile, balancing demand with manufacturing capacity has proven to be one major challenge for commercial CAR-T players. Last summer, Bristol Myers Squibb said demand for its newly launched multiple myeloma CAR-T Abecma was outstripping its production capabilities, which the company blamed on the need to reserve manufacturing slots to make each patient’s personalized therapy plus an industrywide shortage of viral vectors, which are used to deliver cell therapies.
Allogeneic cell therapies’ use of donor cells, rather than a patient’s own, has been heralded as a potential way to increase supply and slash manufacturing timelines, which would in turn get more cancer therapies to patients.
One other cell therapy pitfall on the horizon is pricing and access. As more companies mount the FDA “approval hurdle” with their cell and gene therapies, the challenge will be to deliver those treatments in a way that minimizes “cost shocks” to the system, Brett Sahli, assistant vice president of pharmaceutical trade relations at Prime Therapeutics, said on a recent Fierce Biotech panel.
In ultra-rare conditions, meanwhile, it’s likely payers will get “better and better” at finding ways to cover the next-gen meds, Institute for Clinical and Economic Review President Steven Pearson, M.D., added during the panel. For more prevalent diseases, coverage talks could present entirely new challenges and potentially open the door to government scrutiny and price controls.