ASCO Roundup: Checkpoint Combos, Tumor Profiling, Financial Toxicity

Xconomy National — 

[Note: Ben Fidler coauthored this report.] The American Society of Clinical Oncology conference is wrapping up, and the closely watched medical meeting-slash-hype machine produced its usual array of data. There were a few big business-focused “horse race” stories—one company’s stumble was another company’s gain—but much of the news consisted of mid-trial updates that companies produce because, well, it’s ASCO and everyone is watching.

Drug costs remain a big worry, but there was no galvanizing moment like two years ago, when Leonard Saltz of the Memorial Sloan Kettering Cancer Center fired a broadside at the drug industry over the prices it was demanding for its new drugs.

Saltz was on hand this year, too, and sat for an interview with Medscape that’s worth a read. But there seemed to be a relative lack of headlines about drug costs. There was not, however, a lack of papers trying to measure “financial toxicity” as a side effect that’s just as tangible for a patient as an overheated immune system or debilitating nausea. One study also looked at the barriers that impede doctors from discussing with their patients the financial burdens of medicine. As people digest the ASCO data in the coming weeks, expect to see more discussion of drug costs, such as this urologist’s take in Forbes.

What else was shaking in Chicago? Read on.


—Checkpoint inhibitors, which stymie proteins such as PD-1 and CTLA4 that tumors use to evade the immune system, are now established cancer treatments: six have been approved for skin, lung, bladder, and other cancers.

The two checkpoint leaders—nivolumab (Opdivo, from Bristol-Myers Squibb (NYSE: BMY)) and pembrolizumab (Keytruda, from Merck (NYSE: MRK))—are in a topsy-turvy battle for market supremacy. Last year, nivolumab failed a key trial in newly diagnosed lung cancer patients, and pembrolizumab didn’t. Bristol-Myers is looking to rebound by combining nivolumab with another of its immunotherapy drugs, ipiliumuab (Yervoy), in newly diagnosed lung cancer patients. The latest detailed results from an early-stage study, Checkmate-012, were released Saturday. (A much larger study of the same combination, called Checkmate-227, is ongoing and has not produced public data yet.)

Checkpoint inhibitors continue to expand into other cancers. ASCO featured updates from nivolumab and pembrolizumab studies in liver, stomach, cervical, and colorectal cancers. Merck also reported more data underscoring pembrolizumab’s recent approval for patients with a particular genetic signature, regardless where their tumors originated.

Longtime partners Regeneron Pharmaceuticals (NASDAQ: REGN) and Sanofi (NYSE: SNY) have entered the checkpoint scrum with their PD-1 blocker REGN-2810, starting in an indication with no PD-1 inhibitors, advanced cutaneous squamous cell carcinoma, a type of skin cancer that also has no widely used standard of care. Their Phase 1 results, posted Sunday, were “interesting” but too early to draw much from, Barclays analyst Geoff Meacham wrote in a research note. A Phase 2 study is ongoing.


Just before ASCO, the FDA approved pembrolizumab to treat tumors with a specific genetic fingerprint regardless of the part of the body where they began growing. Over the weekend, Loxo Oncology (NASDAQ: LOXO) added to the enthusiasm for genetically-targeted cancer therapy with Phase 2 data that showed people with a wide range of tumors, all with a mutation called a TRK fusion, responded well to the company’s drug larotrectinib. Shares of Loxo surged more than 43 percent.

Loxo will soon seek to have larotrectinib join pembrolizumab as an approved tumor-agnostic drug, but in the meantime the trial’s lead investigator told Xconomy that the positive results could push more researchers and companies to “engage in this newer paradigm of drug development.”

A big hurdle, however, is acceptance of the tests required to identify a tumor’s signature. The cutting-edge DNA tests are not easily reimbursed and remain confusing for many doctors who don’t have access to the resources of major medical centers, as Xconomy reported last week.

Some of these tests look for TRK fusions, but Loxo’s CEO told Xconomy he is hedging bets, enlisting Roche to develop an older-school (and cheaper) test that looks at a tumor under a microscope.

Meanwhile, companies that make tumor DNA diagnostics were in full force at ASCO. One developer of blood-based diagnostics known as liquid biopsies, Grail, began the ASCO run-up with a merger announcement, then presented early data from its massive clinical study program.

Grail wants to make tests that screen for cancer—that is, detect it in otherwise healthy people. Others have similar ambitions, also using … Next Page »

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