Finding patients with rare diseases is difficult enough, but even more so when diagnostic testing is needed to identify candidates. And the pandemic may be exacerbating the problem.
Bayer’s head of pharmaceuticals says it's been a struggle to find patients for Vitrakvi, its treatment for solid tumors with neurotrophic receptor tyrosine kinase (NTRK) gene fusion—with prospects not improving during the COVID-19 crisis.
Bayer’s Stefan Oelrich told analysts in a call Tuesday that it may be “too sophisticated for physicians to diagnose patients appropriately,” according to a Reuters report. He added that Bayer is working on the problem.
Bayer, in fact, had been working on it for at least a year before the COVID-19 pandemic. The drugmaker launched a cancer diagnostics campaign “Test Your Cancer” last year to encourage patients to seek genomic testing that can identify mutations for targeted treatment. Bayer even soft-launched the effort with an ad in the 2019 Super Bowl program.
It's a big hurdle to overcome. Only 25% of cancer patients discuss genomic cancer testing with their doctors, said Cindy North, Bayer's director of direct-to-consumer oncology marketing, said in an interview about the campaign launch.
Across the industry, makers of targeted drug therapies face similar diagnostic test hurdles. In ovarian cancer, GlaxoSmithKline was able to tout—if briefly—that its PARP inhibitor Zejula doesn’t require the BRCA mutation gene screening in first-line maintenance patients that rival Lynparza from AstraZeneca and Merck does.
Although the impact of the COVID-19 pandemic on diagnostic testing overall is still emerging, there is general evidence that it has slowed or even stopped in some locations. Cancer.org reports a “substantial decline in cancer screening” caused by holds on elective medical procedures that included tests for cancer.
Companies have scrambled to navigate diagnostics even before COVID-19, with some like Bayer promoting tests to help find potential patients and some even offering free services.
BioMarin offers no-cost gene panel testing through its “Behind the Seizure” program with partner Invitae for children with unprovoked seizures. The program can pinpoint epilepsies with genetic causes —and for BioMarin, more quickly identify children with CLN2-specific Batten disease which can be treated with its med Brineura.
Roche has taken an in-house approach to diagnostics, and expanded that push by first funding and then buying a cancer diagnostics company. Now Roche-owned Foundation Medicine provides companion diagnostic options to cancer drug developers that include Bayer, Merck and Pfizer, along with Roche. Roche agreed to the company's independence when it bought the company in 2018.