Immunotherapy is once again hailed as the "clinical cancer advance of year" by the American Society of Clinical Oncology (ASCO) in its annual report.
This is the second time that immunotherapy has won this accolade – it was also declared the clinical cancer advance of the year in last year's report.
It was chosen again this year in recognition of the "growing wave of progress" with immunotherapy that "has extended and improved the lives of patients, many of whom had few other effective treatment options."
During the past year (from November 2015 through October 2016), there has been a wave of new successes with checkpoint inhibitor immunotherapy, the report notes. "Research has proven this approach can be effective against a wide range of hard-to-treat advanced cancers previously considered intractable."
The report lists the progress made both with immunotherapy and with other therapies, much of which has already been reported by Medscape Medical News, as indicated in the links provided below.
Talk of "Cure" in Melanoma
"In just a few short years, immunotherapy has transformed the outlook" for patients with advanced melanoma, the report notes. "Given the lasting responses seen in a large proportion of patients who have received immunotherapy, experts are beginning to speculate that a cure may be within reach, at least for a fortunate few patients."
It highlights in particular new long-term data for pembrolizumab (Keytruda, Merck & Co). Follow-up of 655 patients enrolled in an early clinical trial showed a median survival of 23 months, and the 24-month survival rate was 49%. Tumors had shrunk in one third of the patients, and treatment responses lasted more than 1 year in 44% (JAMA. 2016;315:1600-1609).
These findings are similar to those previously reported for the similar agent, nivolumab (Opdivo, Bristol-Myers Squibb), which showed a 24-month survival rate of 43% among patients with advanced melanoma (J Clin Oncol. 2014;32:1020-1030).
Both survival rates were better than the rate seen with a different type of checkpoint inhibitor, ipilimumab (Yervoy, Merck & Co). An earlier analysis of pooled data from several trials found a median survival of only 11.4 months (J Clin Oncol. 2015;33:1889-1894).
Also in the previous year, improvement in survival was reported with adjuvant ipilimumab in patients with stage III melanoma for which surgical removal was possible, but a high dose of the drug was used (N Engl J Med, published online October 7, 2016).
Changed Paradigm in Lung Cancer
Immunotherapy has changed treatment paradigms in lung cancer, the report notes, adding that "the historical standard treatment of advanced lung cancer (ie, chemotherapy) has finally been displaced."
Pembrolizumab and nivolumab were both approved for second-line use in patients with previously treated non–small cell lung cancer (NSCLC) in 2015, and last year they were joined by a third drug, atezolizumab (Tecentriq, Genentech/Roche).
Pembrolizumab has now been approved for first-line use in NSCLC, after a trial showed improved survival compared with chemotherapy in patients who were positive for programmed cell death ligand 1 (PD-L1) (N Engl J Med, published online October 8, 2016).
"These findings will change initial treatment of metastatic NSCLC in that every newly diagnosed patient will need to be tested for PD-L1," the report comments. "Patients with high PD-L1 levels will likely receive immunotherapy rather than chemotherapy."
Further Approvals in Three New Cancer Types
The past year also saw approvals for immunotherapy in three new cancer types – bladder cancer, head and neck cancer, and Hodgkin's lymphoma.
The approval for bladder cancer for atezolizumab was the first new treatment for the disease in several decades, the report notes. This was an accelerated approval based on improved response rates compared to that seen historically with chemotherapy in an early clinical trial in patients with previously treated metastatic urothelial cancer, the most common type of bladder cancer (Lancet. 2016;87:1909-1920).
Nivolumab was approved for use in the treatment of recurrent or metastatic squamous cell carcinoma of the head and neck after it was shown to improve survival compared to chemotherapy and to have fewer adverse events, thereby improving quality of life for patients (N Engl J Med, published online October 8, 2016).
Hodgkin's lymphoma seems particularly susceptible to programmed cell death inhibitors, the report notes. Nivolumab was approved for Hodgkin's lymphoma after an early clinical trial showed that lymphoma went into remission in 53 (66%) of 80 patients and disappeared entirely in seven patients. (Lancet Oncol. 2016;17:1283-1294). Nearly all patients with classic Hodgkin's lymphoma who responded to the treatment had at least a 50% reduction in the amount of cancer in the body, and responses lasted 8 months on average. Pembrolizumab has also shown activity in this indication (J Clin Oncol. 2016;34:3733-3739).
Advances in Cancer Therapy Beyond Immunotherapy
In addition to the growing success seen with immunotherapy, 2016 was marked by a wave of advances in precision medicine–based approaches," the report states. Among the advances highlighted are the following:
Need for Federal Funding of Research
The report also highlights the need for "sustained, robust federal funding for continued research and innovation."
Approximately 30% of the research highlighted in the report was funded, at least in part, through federal dollars allocated to the National Institutes of Health or the National Cancer Institute, notes ASCO president Daniel Hayes, MD, in a foreword.
"Without this federal investment — unique internationally in scale, duration, and impact for decades — I fear we may lose the forward momentum needed to further the progress we see highlighted in this report," he comments.