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 drugmakers showed that the use of immunotherapy in combination with other drugs did a better job of treating lung cancer than chemotherapy alone.
A combination of Merck's immunotherapy drug, Keytruda, and chemotherapy cut the risk death in lung cancer patients by half.
The results could massively impact the way hundreds of thousands of lung cancer patients are treated, by making immunotherapy part of the standard treatment.
A new kind of cancer treatment that harnesses the body's immune system, known as immunotherapy, 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 showed that a combination of the immunotherapy Keytruda with chemotherapy was able to extend the lives of people with a common form of lung cancer compared to traditional chemotherapy, cutting the risk of death by half.
At the same time, Bristol-Myers Squibb, which makes a competing immunotherapy, Opdivo, showed that its drug in combination with Yervoy, another immunotherapy, managed to keep lung cancers that had a certain amount of mutations from getting worse for a longer period of time than those treated with chemotherapy.
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Unlike chemotherapy, which involves administering powerful drugs that kill both cancerous and healthy cells (most healthy cells can repair themselves), immunotherapies harness the power of the immune system to help it identify and knock out just the cancerous cells. But just like chemotherapy and radiation, immunotherapy can have side effects, but they tend to look very different than those from the other treatments.
The results have big implications on the way lung cancer is treated by making immunotherapy a part of the standard way the cancer's treated. According to the American Cancer Society, there are about 234,000 new cases of lung cancer each year. Around 80% to 85% of those cases are a type of lung cancer called non-small cell lung cancer, which these trials focused on. Overall, lung cancer is the second-most common cancer next to breast cancer in women and prostate cancer in men.
This is a competitive field. Opdivo, a PD-1 inhibitor which was originally approved in 2014, made $4.9 billion in revenue in 2017, while Yervoy – initially approved in 2011 — made $1.2 billion. Opdivo's approved to treat a number of different forms of cancer, and in later-stage lung cancer, while Yervoy is approved to treat melanoma. Keytruda, which works in a similar way to Opdivo and was approved initially in 2014, made $3.8 billion in revenue in 2017.
And each company's approach to tackling advanced lung cancer is slightly different. Here's how they stack up.
Keytruda and chemotherapy
In a phase 3 trial, Merck randomized 616 patients with advanced or metastatic nonsquamous non-small cell lung cancer to either receive a combination Keytruda with chemotherapy (pemetrexed and platinum) or the chemotherapy combined with a placebo drug.
Of the 4o5 patients that were part of the group that received the immunotherapy, the rate of overall survival at the end of 12 months was 69.2%. In the group that received just chemotherapy, that overall survival rate was 49.4%
Progression-free survival — a clinical endpoint that basically means the cancer hasn't grown — was a median of 8.8 months in those who received Keytruda, while those in the chemotherapy group had a median progression-free survival of 4.9 months. The results were not dependent on how much PDL1 — a protein associated with the target Keytruda acts on — was expressed in their body, though those that had more tended to do better. The hazard ratio for death was .49, meaning those who received immunotherapy and chemotherapy were half as likely to die as those who received chemotherapy alone.
Merck already got FDA approval in May 2017 to treat lung cancer using Keytruda and chemotherapy based on data from a phase 2 study.
Dr. Leena Gandhi, the principal investigator on the trial presented Monday and the director of the thoracic medical oncology program at Perlmutter Cancer Center at NYU Langone Health, also led that phase 2 study. Gandhi said that she didn't change her practice and make immunotherapy part of her standard treatment for lung cancer patients based on those earlier results. That changes now that she has the survival data from the phase 3 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 its combination of its immunotherapy drugs — Opdivo and Yervoy — compared to chemotherapy in a certain group of lung cancer patients. It's the only company coming out with a strictly immunotherapy-based regimen compared to chemotherapy.
The trial found that the combination managed to keep lung cancer patients' disease with a high amount of tumor mutations from progressing longer than those treated with chemotherapy. The median progression-free survival in the 139 patients treated with the immunotherapy combination was 7.2 months compared to the 160 treated with chemotherapy, whose median 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 it and go after it. In lung cancer patients who had high TMB (45% of the patients in the trial qualified), the treatment was considered superior to chemotherapy in keeping cancer from progressing.
"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," David Fabrizio, head of immunotherapy at Foundation Medicine, told Business Insider. BMS uses Foundation Medicine's test to figure out the TMB for each patient.
Rochealso shared its progression-free survival data at the conference on Monday. According to data released Friday, of the 692 patients that took part in the trial, those that received a combination of the company's cancer immunotherapy Tecentriq with one of its other cancer drugs, Avastin, along with carboplatin and paclitaxe had a median progression-free survival of 8.3 months, while the group in the trial that received Avastin and the chemotherapy without the immunotherapy had a median of about 6.8.
That benefit was the same regardless of how much PD-L1 the patients expressed. 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, carboplatin and paclitaxel alone.