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Another Precision Step for Roche as Ignyta Drug Heads to Regulators

Xconomy San Francisco — 

There was more news this morning in the advancement of precision cancer drugs, which target a tumor’s genetic signature. Roche plans to file for approval of entrectinib, a drug the Swiss firm acquired when it bought San Diego, CA-based Ignyta for $1.7 billion last year.

Roche’s Genentech unit provided updated data pooled from three early and mid-stage studies called STARTRK-1, STARTRK-2, and ALKA. Combined, the three studies tested entrectinib in 53 patients whose tumors have specific genetic alterations—NTRK or ROS1 fusions.

Roche said in a statement 77.4 percent of patients in the studies with advanced non-small cell lung cancer and a ROS1 fusion responded to entrectinib, and their responses have lasted a median of 24.6 months. Entrectinib also shrunk tumors in 55 percent of patients’ whose tumors had spread to the central nervous system, Roche said.

Roche presented the data at the World Conference on Lung Cancer in Toronto on Monday, and said in its statement that based on the results it plans to file for entrectinib approval in the U.S. and abroad. It’s starting with an approval application for ROS1-positive lung cancer, which affects some 1 to 2 percent of people with the disease. But Roche is aiming for a “tissue-agnostic” drug approval as well—that is, an approval to treat tumors with specific genetic signatures, regardless of where in the body they form. The company is testing entrectinib in a variety of different tumors with NTRK fusions and plans to reveal those results “in the near future,” Genentech chief medical officer Sandra Horning said in a statement. NTRK fusions are found in more than 30 different solid tumor types.

Entrectinib is one of an increasing number of cancer drugs being advanced toward a tissue-agnostic approval. The agency gave the first such approval in May 2017 to Merck’s (NYSE: MRK) pembrolizumab (Keytruda). Loxo Oncology (NASDAQ: LOXO) could be next and win FDA approval of its drug larotrectinib, which targets TRK fusions, an abnormality present in 0.5 percent to 1 percent of solid tumors, by Nov. 26.

Other tumor-agnostic drugs from Loxo, Eli Lilly (NYSE: LLY), and more are advancing through clinical testing (here’s a look from Nature at the increasing pipeline of tumor-agnostic drugs.).

As they get to market, these drugs will have to break ground commercially, starting with larotrectinib. Merck’s pembrolizumab was already approved for several cancers and commercially entrenched when it got its landmark approval. Larotrectinib, by comparison, headed to the FDA earlier this year based on data in 55 patients with 17 different types of cancer. Will the FDA approve larotrectinib for all patients with TRK fusions? Will payers use a single price regardless of the cancer type, or a set one according to a drug’s tissue-specific effectiveness? And will the broad tumor-profiling tests that can detect rare genetic abnormalities like TRK and ROS1 fusions be widely covered by insurers?

Here’s more on the advancement of tumor-agnostic cancer drugs and the commercial questions they face.