While media appoints Keytruda king Oncologists say “show me the data”

KEY TAKEAWAY:  The news out of AACR, from the media’s standpoint, is that Keytruda (Merck) scored a huge win with the press release that cancer patients can live longer with Keytruda and chemotherapy, but beyond the hype doctors are questioning the data and saying “I need to more”.

The pharmaceutical industry is making inroads against cancer and that’s great news for patients, but Oncology is a very complicated medical practice.  The media, however, hungry for any news is blasting Merck’s press releases all over the Internet.  However, doctors aren’t so sure.

Based on a Medscape poll, 52% of medical professionals were unsure or said no using the Keytruda combination as a frontline therapy.

In addition, some doctors are saying they want to see the data firsthand.

But what about patients?  Patients want a good quality of life but the side effects were almost universal — 99.8 percent of patients who received Keytruda and chemotherapy experienced them. And among those in the comparison group, who got a placebo and chemotherapy, 99 percent reported side effects. The most common issues in both groups were nausea, anemia and fatigue.

So will patients want to deal with these nasty side effects for a few more months of life?  And then there is the cost of the combination treatment which could be prohibitive to some patients.

BMS Takes a Different Approach

BMS’s trial looked at how the combination of its immunotherapy drugs, Opdivo and Yervoy, compared with chemotherapy in a group of people with lung cancer. It was the only company coming out with a treatment based strictly on immunotherapy.

In addition to being the only trial based strictly on immunotherapy, BMS’s also was the only one to use a biomarker called tumor mutation burden. The idea is that the more mutations a tumor has, the more likely the immune system will be able to recognize and go after it.

The trial found that of the patients with a high TMB — 45% of the patients in the trial qualified — the combination managed to prevent progression longer than for people treated with chemotherapy. The median progression-free survival in the 139 patients treated with the immunotherapy combination was 7.2 months, while in the 160 treated with chemotherapy it was 5.5 months.

“It’s a journey. What you’re seeing today is the tip of the iceberg,” Namouni said. “More work is needed to better understand this disease and continue to bring combinations like Opdivo and Yervoy to patients. But not every patient’s the right patient in our case.”

Namouni said the reason for going more precise, as opposed to taking the broader route that other cancer drugmakers have taken, stems from the way we’ve learned about infectious disease.

“I don’t think we’re going to go backwards,” he said. “I think we can only go forward by being very precise and understanding the drivers of a given disease, not just to the organ where the disease belongs, but the real driver of cancer and then target that with some medicine.”

In the end the battle of press releases is only having an effect on the stock price because analysts like to wage bets.  Oncologists are the ones who are going to make the ultimate decision about which treatment is recommended for patients with NSLC.  Right now the jury is out…

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