Nivolumab FDA approved for patients with metastatic small cell lung cancer (SCLC)

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By: scienterrific | Last updated: 21 August 2018 | In: US FDA Onc\Haem Approvals, Lung Cancer, Oncology, Immunotherapy

Article Keywords

PD-1, PD-L1, nivolumab, FDA, BMS, Bristol-Myers Squibb, Opdivo, chemotherapy, platinum-doublet, SCLC

On the 16th of August 2018, the FDA granted accelerated approval to nivolumab (Opdivo®, Bristol-Myers Squibb) for use in patients with metastatic small cell lung cancer (SCLC) who progressed after two lines of therapy, including one line of platinum-based chemotherapy.

Clinical Data

The CheckMate 032 (NCT01928394) was a multicenter, open-label trial of nivolumab or nivolumab plus ipilimumab (Yervoy®, Bristol-Myers Squibb) in patients with metastatic solid tumours. The study encompassed a subgroup of 109 patients with metastatic SCLC and any PD-L1 expression whose disease progressed after two lines of prior therapy including at least one line of platinum-based chemotherapy. All 109 patients received single-agent nivolumab. The primary study endpoints were overall response rate (ORR) and the duration of response (DoR) by blinded independent central review using RECIST 1.1.

In this patient population, 13 out of 109 patients treated with single-agent nivolumab showed a response by RECIST 1.1 to the treatment matching an ORR of 12% (95% CI, 6.5-19.5). Responses with a duration of ≥6 months were observed in 77% (10/13) of patients, a duration of ≥12 months in 62% (8/13) of patients, and a duration of ≥18 months in 39% (5/13) patients. The PD-L1 tumour expression status was not predictive of response.

Safety

The safety assessment included a larger cohort of metastatic SCLC patients (N=245) whose disease had progressed following platinum-based chemotherapy and who had received at least one dose of nivolumab.

The most common adverse reactions in ≥20% of SCLC patients in the CheckMate-032 trial were fatigue, decreased appetite, musculoskeletal pain, dyspnoea, nausea, diarrhoea, constipation and cough.

Serious adverse reactions occurred in 45% of patients. The most frequent serious adverse reactions in ≥2% of patients included pneumonia, dyspnoea, pneumonitis, pleural effusion, and dehydration. Ten percent of patients discontinued nivolumab due to adverse reactions and 25% of patients had ≥1 dose(s) withheld for adverse reactions.

Opdivo® prescribing information

Disclaimer

This article is not medical advice. Patients should seek personal assessment by a licenced specialist. Physicians are recommended to read the full publication(s) as cited in the article before making medical decisions. This article does not supersede nor replace the published article(s).

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