First Drug Approved for Small Cell Lung Cancer in 20 Years: The Immunotherapy Nivolumab

Previously, with platinum -based chemotherapy and at least one other treatment, disease progression in metastatic (stage 4) small cell lung cancer patients led to approval of the immunotherapy drug nivolumab (brand name Opdivo), on 17 August 2018, with accelerated FDA approval.

Platinum-based chemotherapies used for first-line small cell lung cancer treatment produce high tumor response rates of % 60-80; however, even among early-stage patients (disease confined to the chest), only around % 20 achieve a complete cure. In most patients, cancer relapses (recurs) months after initial treatment ends. In the second line, meaning treatment of recurrent or progressive small cell lung cancer, topotecan is the only FDA-approved drug. This demonstrates how limited small cell lung cancer treatment options are.

No new drug had been approved for small cell lung cancer treatment in approximately the past 20 years; approval of the immunotherapy nivolumab in this disease is therefore a particularly noteworthy development in oncology.

Immunotherapies activate immune system cells against cancer cells to exert anticancer effects. The figure below illustrates the mechanism of including nivolumab, immune checkpoint inhibitor immunotherapies.

The FDA, based on data from part of the ongoing CheckMate-032 phase 1/2 clinical trial, approved nivolumab for treating advanced small cell lung cancer.

Within this study, 109 small cell lung cancer patients, PD-L1 regardless of status,were treated every 2 weeks with nivolumab at 3 mg / kg. The first tumor assessment was performed 6 weeks after treatment started, then for 6 months every 6 weeks, and subsequently every 12 weeks.

The study found that;

• 13 patients (% 12) had an objective response; 12 had a partial response and 1 had a complete response to treatment.
• Among responding patients, the median duration of response was 17.9 months.

The most frequently reported, occurring in at least % 2 of patients, serious adverse effects were pneumonia, dyspnea (shortness of breath), pneumonitis (a type of lung inflammation), pleural effusion (fluid between the lung membranes) and dehydration (fluid loss). The most common adverse effects occurring in at least % 20 included fatigue, decreased appetite, musculoskeletal pain, dyspnea, nausea, diarrhea, constipation and cough.

- Related Topic: What Are Immunotherapy Drug Adverse Effects, and How Are They Treated?

Based on overall response rate and response duration, nivolumab received accelerated approval ; final confirmation of this approval will depend on verifying its benefit in future studies.

Nivolumab also, for patients whose disease progressed during or after platinum-based chemotherapy and who had stage 4 non- small cell lung cancer, received FDA approval in 2014.

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