Armed with FDA nod, Otsuka unit Astex preps to launch oral chemotherapy Inqovi

Astex Pharmaceutical created an oral formulation of a widely-used blood cancer chemotherapy, providing patients with an option beyond IV. (tonaquatic/GettyImages).

For nearly two decades, blood cancer patients have depended upon time-consuming infusions of the chemotherapy decitabine. Now, with an FDA approval for Astex Pharmaceuticals' oral version, they have an alternative.

Astex's Inqovi scored FDA approval to treat intermediate- and high-risk myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML), becoming the first oral drug of its kind for those patients, the company said.

Inqovi pairs decitabine—an established anti-cancer drug—with cedazuridine, which inhibits the chemotherapy-thwarting enzyme cytidine deaminase. By silencing cytidine deaminase in the gut and liver, cedazuridine stops the body from breaking down decitabine, making its oral delivery possible. 

Inqovi is taken once daily by mouth over five days, with patients repeating that regimen every 28 days. The treatment cycle follows the same general timeline for IV decitabine, minus trips to the clinic and lengthy stays in infusion chairs. 

That time-saving potential, plus the added safety and convenience of an at-home chemotherapy, could provide MDS and CMML patients with a much-needed alternative to traditional IV treatments, Astex says. 

“Until now, patients with intermediate and high-risk MDS and CMML have not had an approved, orally administered hypomethylating agent option for treatment of their disease,” said Mohammad Azab, M.D., president and CMO at Astex, which is itself a unit of Japan-based Otsuka Pharmaceuticals.

On average, MDS and CMML patients are in their 70s, making the strain of in-person visits to infusion clinics even more taxing, Azab told FiercePharma. The tablet version can thwart any obstacles to those visits—such as pandemic-related restrictions—and help keep patients on their prescribed doses. "By reducing the burden on patients, it will make it easier to adhere to treatment over long periods which may extend to a few years," Azab said.

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In late-stage trials, Inqovi yielded decitabine exposure on par with IV, the company said. The drug generally matched its intravenous counterpart in safety as well, with the most common side effects ranging from mostly mild reactions like nausea, fatigue and headache to slightly more severe events like febrile neutropenia, pneumonia and upper respiratory tract infection. 

Astex will hand off marketing duties to Taiho Oncology, its sister company under the Otsuka umbrella. With an oncology salesforce locked into place—and prior experience bringing another oral chemotherapy, Lonsurf, to market—Taiho will initially target around 1,500 hematologists and oncologists, plus oncology nurses and pharmacists, president and CEO Tim Whitten said. 

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One other ace up Taiho's sleeve? There's about a two-thirds overlap between Taiho Oncology's current HCP customer base and the MDS and CMML patients who could benefit from Inqovi, Whitten said. 

Meanwhile, Astex is aiming for additional Inqovi indications in other blood cancers that develop out of MDS. Intravenous decitabine has conditional approval in combination with Venclexta (venetoclax) for myeloid leukemia patients who cannot handle intense chemotherapy; it's Astex's hope that Inqovi, in combination with other treatments commonly paired with IV decitabine, could win approval for that condition, too, Azab said. Trials are already underway to pursue that additional nod.