FDA Approval of Nivolumab Life Changing for Patients, Paradigm Shifting for the Cancer Immunotherapy Field

March 6, 2015

The recent FDA approval of Bristol-Myers Squibb’s nivolumab (Opdivo®) validates cancer immunotherapy as a viable option for treating advanced squamous non-small cell lung cancer (NSCLC), a subset of the leading cause of cancer-related deaths worldwide.

“The approval of nivolumab for squamous NSCLC is nothing short of groundbreaking,” said SITC Member Naiyer A. Rizvi, MD, Columbia University Medical Center. “As we look back to 2008 when the first lung cancer patient was treated with nivolumab, it is hard to have imagined that immunotherapy would have been so successful. Anti-PD-1 antibodies have changed the lives of many patients with lung cancer and it is exciting to see that nivolumab will now be available more broadly for patients.”

In 2014, an estimated 224,210 new diagnoses and 159,260 lung cancer-related deaths were reported in the United States alone, according to the FDA. Making up between 25 and 30 percent of all lung cancers, squamous cell carcinoma is one subset of lung cancer. Approval of this cancer immunotherapy gives physicians a powerful new tool—and patients a new hope—for treating this deadly disease.

What the Approval Means for the Field

The cancer immunotherapy field has seen rapid progress in the last few years. Since November 2013 alone, numerous immunotherapies have been approved by the U.S. FDA for treating rare (many considered “immunogenic”) cancers, including: obinutuzumab + chlorambucil and ofatumumab + chlorambucil (chronic lymphocytic leukemia), ramucirumab (gastric), siltuximab (Castleman’s disease), bevacizumab (cervical), pembrolizumab (melanoma) and nivolumab (melanoma). Nivolumab for lung is the latest immunotherapy to receive U.S. FDA approval, the first for lung.

“The approval of nivolumab for the treatment of lung cancer is paradigm shifting for the field,” stated SITC President Howard L. Kaufman, MD, FACS, Rutgers Cancer Institute of New Jersey. “Not only does the approval bring an important new option for patients with lung cancer, but it also supports the increasing role of immunotherapy as a viable option for the treatment of all cancers worldwide.”

What this Means for Patients

Nivolumab is a monoclonal antibody that targets the programmed cell death 1 (PD-1) receptor expressed on T cells. PD-1 functions to suppress T cell activity and nivolumab blocks this suppression releasing the T cells to mediate tumor regression. Two PD-1 targeted agents, nivolumab and pembrolizumab, were approved by the FDA for the treatment of advanced melanoma in 2014.

The safety and efficacy of nivolumab to treat squamous NSCLC was supported by a single-arm clinical trial (CheckMate -017) of 117 participants who had progressed after receiving a platinum-based therapy and at least one additional systemic regimen. The study was designed to measure objective response rate (ORR), or the percentage of participants who experienced partial shrinkage or complete disappearance of the tumor. Results showed 15 percent of participants experienced ORR, of whom 59 percent had response durations of six months or longer.

For patients with squamous NSCLC, this approval is life changing. A second-line, non-chemotherapy option, nivolumab is a well-tolerated treatment; patients who undergo this therapy experience fewer and less severe side effects and are able to lead more normal lives.

What’s Next?

According to SITC Member Julie R. Brahmer, MD, Johns Hopkins Kimmel Cancer Center, the next step is to “personalize the therapy,” or identify those for whom the therapy will most likely be effective. “Biomarkers of response are being evaluated. Additionally, investigators are studying ways to increase the response rate to immunotherapy in more patients.”

SITC’s Work in Biomarkers and ImmunoScore

Due to advances in cancer immunotherapy, including positive results from clinical trials testing new agents and combinations, emerging new technologies for measuring aspects of immunity and novel candidate biomarkers from early phase trials, SITC has reconvened the Immune Biomarkers Task Force to review the state of the art, identify current hurdles to further success and to make recommendations to the field.

Additionally, SITC and three other organizations jointly organized the Immunoscore Project as a possible approach in the classification of cancer. This SITC-led initiative includes representatives from 17 countries and 23 centers and more than 5,000 patients.

Media Contacts

Naiyer A. Rizvi, MD
Columbia University Medical Center

Julie R. Brahmer, MD
Johns Hopkins Kimmel Cancer Center

Call +1 414-271-2456 and ask for SITC Marketing, or submit your interview requests here.