Soaring cost, toxic effects drive race for cancer tests

“It’s clear it’s going to be able to identify people who have huge benefits, and people who have small benefits,” said Briggs Morrison, chief medical officer at AstraZeneca. Yet drug companies “are definitely not there yet” in devising a standard test that all patients can use.

To perform tests for PD-L1 proteins, doctors sometimes rely on tumor samples that may be months or years old. Amounts of PD-L1 may vary from one part of the tumor to another. And the tests don’t look at whether there are any immune cells nearby that are ready to attack the tumor with the drugs’ help.

Combination drugs

Older, more established cancer treatments, such as Roche’s blockbuster breast cancer drug Herceptin, come with tests to identify the minority of patients who are most likely to benefit from them.

The need for a similar test for the immune therapy drugs is becoming even more important as companies seek to combine new therapies for greater effectiveness — increasing both side effects and price.

In one study highlighted at the ASCO meeting, two Bristol-Myers melanoma drugs, Opdivo and Yervoy, delayed progression of the disease for months more than either drug did alone. But the combination was far more toxic.

Also, the cocktail will cost about $295,000 for an average-weight patient in just under a year, according to estimates presented at the conference by Leonard Saltz, an oncologist at Memorial Sloan Kettering Cancer Center, who has long expressed concern that cancer drugs are too costly. If similarly priced combinations were given to every American with advanced cancer, it would cost the country $174 billion a year, Saltz said at the meeting.

This prospect isn’t as far-fetched as it may sound. Immune drugs have shown promise in a wide array of tumors, including lung cancer, kidney cancer, liver tumors, bladder cancer, head and neck tumors, and even some forms of colon cancer.

Bristol-Myers declined to confirm a price for the combination.

Lone test

While PD-L1 has flaws as a measure of drugs’ effectiveness, “it’s the only real one out there right now,” said Asthika Goonewardene, an analyst at Bloomberg Intelligence. That makes it useful for drug companies seeking to show cancer doctors why they should use one treatment over another, Goonewardene said.

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“Roche and Merck will be cramming this down doctors’ throats using it as a tool to differentiate their drugs” from Bristol-Myers’ Opdivo, he said. Opdivo was first to reach the market for lung cancer, likely to be the single biggest market for these drugs.

And even if the tests are imperfect, insurers may use them to decide who gets coverage.

“Payers around the world and in the U.S. — they’re very interested in making sure they’re only going to treat patients who have the potential to benefit,” said Daniel O’Day, chief operating officer for Roche’s pharmaceutical unit.