- New cancer treatments that harness the body’s immune system are ready to go mainstream.
- In data presented Monday at the American Association of Cancer Research’s annual meeting, cancer-drug makers found that immunotherapy in combination with other drugs did a better job of treating lung cancer than chemotherapy alone.
- A combination of chemotherapy and Keytruda, Merck’s immunotherapy drug, cut the risk of death in people with lung cancer by half, according to the data.
- The results could make immunotherapy part of the standard treatment, massively affecting hundreds of thousands of people with lung cancer.
Immunotherapy, a new kind of cancer treatment that harnesses the body’s immune system, is going mainstream.
In data presented Monday at the American Association of Cancer Research’s annual meeting and published in the New England Journal of Medicine, Merck found that a combination of the immunotherapy drug Keytruda and chemotherapy was able to extend the lives of people with a common form of lung cancer when compared with traditional chemotherapy, cutting the risk of death in half.
Meanwhile, Bristol-Myers Squibb found that its immunotherapy drug in combination with another managed to keep lung cancers that had a certain number of mutations from getting worse for a longer period than those treated with chemotherapy.
Unlike chemotherapy, which involves administering powerful drugs that kill both cancerous and healthy cells (most of which can repair themselves), immunotherapies are designed to help the immune system identify and knock out just the cancerous cells. Immunotherapy can have side effects, but they tend to look very different from those of the other treatments.
The results have big implications for lung cancer treatment, as they could make immunotherapy a part of the standard.
According to the American Cancer Society, there are about 234,000 new cases of lung cancer in the US each year. About 80% to 85% of them are non-small-cell lung cancer, on which these trials focused. Overall, lung cancer is the second-most common cancer among Americans, next to breast cancer in women and prostate cancer in men.
Immunotherapy is a competitive field. Opdivo, approved in 2014, made $4.9 billion in revenue last year, while Yervoy, approved in 2011, brought in $1.2 billion. Both are made by BMS.
Opdivo is approved to treat several forms of cancer, including later-stage lung cancer, while Yervoy is approved to treat melanoma.
Keytruda, which works similarly to Opdivo and got approval in 2014, made $3.8 billion in revenue in last year.
Each company’s approach to tackling advanced lung cancer is slightly different. Here’s how they stack up.
Keytruda and chemotherapy
In a phase-three trial, Merck randomized 616 people with advanced or metastatic nonsquamous non-small-cell lung cancer to either receive a combination of chemotherapy and either Keytruda or a placebo.
Of the 405 people who were part of the group that received the immunotherapy, the rate of overall survival at the end of a year was 69.2%. In the group that received just chemotherapy, it was 49.4%.
The median progression-free survival – a clinical endpoint that basically means the cancer hasn’t grown – was 8.8 months for those who received Keytruda and 4.9 months for the chemotherapy-only group.
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The results were not dependent on how much PDL1 – a protein associated with the target Keytruda acts on – was expressed in a person’s body, though those who had more tended to do better.
The hazard ratio for death was 0.49, meaning those who received immunotherapy and chemotherapy were half as likely to die as those who received chemotherapy alone.
Merck got approval from the Food and Drug Administration in May to treat lung cancer using Keytruda and chemotherapy based on data from a phase-two study.
Leena Gandhi, the principal investigator in the trial presented Monday, also led that phase-two study.
Gandhi, the director of the thoracic medical oncology program at NYU Langone Health, said she didn’t change her practice to make immunotherapy part of her standard treatment for lung cancer based on those earlier results, but that it would change now that she has the survival data from the phase-three trial.
“It means that we are going to have lung cancer patients living longer and better than they did in the past,” Gandhi told Business Insider.
That could raise the bar for what it takes to treat lung cancer.
“Our position is that this really does become the floor that any new treatment is going to have to beat,” Roy Baynes, Merck’s senior vice president of clinical development, told Business Insider.
Combining Opdivo and Yervoy
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’s the only company coming out with a treatment based strictly on immunotherapy.
The trial found that the combination managed to prevent the progression of a cancer with a high number of tumor mutations 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.
BMS’s was the only trial 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. Among people with lung cancer who had high TMB – 45% of the patients in the trial qualified – the treatment was considered superior to chemotherapy in preventing progression.
“This will be a landmark day, because it is the first proof for that – and not only that, it is the first proof in a large, randomized, first-line lung cancer trial, so the biggest disease in cancer, a first-line indication,” said David Fabrizio, the head of immunotherapy at Foundation Medicine, which produces a test BMS uses to figure out the TMB for each patient.
The pharmaceutical company Roche also shared its progression-free survival data at the conference on Monday.
Among the 692 people who took part in the trial, those who received a combination of the company’s immunotherapy drug, Tecentriq, one of its other cancer drugs, Avastin, and two chemotherapy drugs had a median progression-free survival of 8.3 months, while it was about 6.8 months for those who had only Avastin and the chemotherapy.
That benefit was the same regardless of how much PD-L1 the patients expressed, Roche said.
Data on overall survival was not included, but in March, Roche said the combination helped people with advanced non-squamous non-small-cell lung cancer “live significantly longer” than those who received Avastin and the two chemotherapy drugs alone.