Deciphera muscles through Qinlock pandemic launch, sets sights on global and pipeline expansion

Deciphera CEO Steven Hoerter
Deciphera CEO Steven Hoerter led the company to its first approval and launch in 2020—and, now, he's looking to global expansion and a growing pipeline. (Deciphera)

In January 2020, Deciphera was eagerly anticipating its first-ever drug approval. And that green light did come—three months earlier, in fact, than the company had expected.

But sandwiched between the January hopes and the gratifying May approval for Qinlock to treat advanced gastrointestinal stromal tumors (GISTs) was the beginning of the COVID-19 pandemic.

Like most drugmakers that launched a new med last year, Deciphera revamped its Qinlock rollout plans. But it had already laid the groundwork, building a sales team from scratch and arming the reps with data to hone their efforts.

Analyzing claims data from late 2019 and early 2020, Deciphera had uncovered the drug's target oncology practices and individual physicians among those treating GISTs, CEO Steven Hoerter said. The new field reps took those lists and reached out—albeit in pandemic-forced digital ways—to confirm their targets.

When recruiting its new field force, Deciphera chose reps in part for their existing relationships with target oncologists. When the pandemic forced a switch to digital, that checked box became even more important.

“Relationships are important, and we looked at that when we built our team,” Hoerter said. “But even with physicians where we didn’t have preexisting relationships, the team has done a good job reaching out, establishing credibility and sharing the right information. Hopefully, this will serve as a strong foundation for us as we move into a post-pandemic environment.”

RELATED: New drug approvals hit a high note in 2020 but face uncertainty in 2021

When Qinlock launched, the first prescriptions came mainly from academic research centers and hospitals that participated in clinical trials. But the reach quickly expanded to community oncologists, Hoerter said. By the end of the year, more than 50% of Qinlock prescribers were oncologists in group practices affiliated with hospitals.

Qinlock is approved as a fourth-line treatment after cancer therapies such as Novartis’ Gleevec, Pfizer’s Sutent and Bayer’s Stivarga. Key to its growth will be expanding into earlier lines of therapy, and upcoming phase 3 data in second-line GIST could help. That trial is expected to read out later this year.

Now, with one approval under its belt, Deciphera is plotting its next moves. For Qinlock, it means geographic expansions in Canada and Australia, with decisions there facilitated through the FDA’s Project Orbis. It's looking to regulatory action in Europe in the second half of the year and building out a launch team there. And its partner in China, ZyLAB, expects a decision there in the first half of the year.

RELATED: Deciphera fills in where Blueprint falls short with early FDA nod in rare stomach cancer

Sales for Qinlock, at a list price of $32,000 per month, topped $15 million in the third quarter and $19.5 million in the fourth quarter.

The other key plan for 2021 is advancing the Deciphera pipeline.

“With our first approval, we’re not only officially a commercial company, but we have other interesting product candidates that are starting to declare themselves as future medicines,” Hoerter said.

Piper Sandler analyst Christopher Raymond agrees. In a November note to clients—headlined “Don't Look Now, But We Got Ourselves a Pipeline"—Raymond reported then-new data on DCC-3014, now named vimseltinib, in phase 1 studies for tenosynovial giant cell tumor treatment.

In the second half of this year, Deciphera's expecting updated phase 1/2 data on vimseltinib, a colony-stimulating factor 1 receptor inhibitor.

A second Deciphera candidate, rebastinib, is expected to report data from a phase 1b/2 study in patients with endometrial cancer. Results in a different patient group—women with platinum-resistant ovarian cancer—are expected in the second half of the year.