Can Stivarga crack the code? Bayer hunts for rare glioblastoma nod with 'Big 5' contender

Bayer is hoping its sales underperformer Stivarga can crack the code for hard-to-treat glioblastoma in new trials. (Bayer)

Touted as one of Bayer’s “Big 5” growth prospects, cancer med Stivarga has trod a rocky path to success under the drugmaker’s lofty moniker. But despite up-and-down sales, Bayer still has high hopes for the drug—and it thinks a hard-to-attain glioblastoma indication could be the answer.

Bayer has opened U.S. trial enrollment for newly diagnosed and recurrent glioblastoma patients as part of GBM AGILE, the drugmaker’s international study platform that will open in more than 40 U.S. trial settings by the end of this year and across Europe, China, Canada, and Australia in 2020. Glioblastoma, an aggressive form of brain cancer with limited treatment options, has a patient fatality rate as high as 95% five years after diagnosis, Bayer said.

“We are excited that the (Stivarga) arm of the GBM AGILE trial is the first to enroll patients and are looking forward to seeing how (the drug) can potentially help these patients in need of treatment options,” Scott Fields, Bayer’s oncology chief, said in a statement.

Stivarga’s sales have pitched up and down in recent years after Bayer pinned high ambitions on the drug’s future. In the first quarter, Stivarga overshot analyst forecasts after a higher-than-expected volume uptake in China with a 26% bump to €97 million.

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But prior to that, Stivarga’s sales were middling, with a 2018 haul that matched the previous year’s. Last year, Stivarga generated €315 million—the exact same amount as 2017. Both Stivarga and its partner cancer med Nexavar, which also underperformed in 2018, joined China’s National Drug Reimbursement list in 2019, giving them much-needed boost to sales.

If Stivarga is successful in roping a notoriously difficult approval in glioblastoma, it could help the drug break out of colorectal and liver cancer markets steeped in blockbuster competitors.

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After Stivarga's approval as a second-line treatment for liver cancer in April 2017, Bristol-Myers Squibb’s blockbuster I-O med Opdivo received a nod of its own months later, putting immediate pressure on Bayer’s hopes. The next year, Merck’s Keytruda joined the fray with its own FDA nod in liver cancer, and one for Eli Lilly’s Cymraza followed in May of this year.

That sales pressure makes glioblastoma an interesting choice for Stivarga’s next pursuit, considering the wasteland of drug prospects the hard-to-treat cancer has left in its wake. As recently as May, AbbVie’s antibody-drug conjugate hopeful Depatux-M showed no survival benefit in newly diagnosed glioblastoma in a phase 3 trial, effectively ending the drug’s chances.

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That same month, Opdivo also couldn’t face the challenge, failing to extend the lives of newly diagnosed patients with glioblastoma multiforme when compared with chemo plus radiation in a phase 3 study. However, there is some hope after Keytruda showed promising data in extending patients’ lives in early-stage trial results released earlier this year.