From the Journals

Nivolumab helps some with advanced NSCLC reach 5-year mark

 

Key clinical point: The programmed death-1 inhibitor nivolumab (Opdivo) is associated with long-term survival in a subset of patients with heavily pre-treated advanced non-small cell lung cancer (NSCLC).Major finding: The estimated 5-year overall survival rate was 16%.Study details: Follow-up study of 129 patients with NSCLC treated with nivolumab in a phase 1 study.

Disclosures: The study was supported by Bristol-Myers Squibb and Ono Pharmaceuticals. Dr. Gettinger and multiple co-authors reported consulting/advisory roles and research finding with BMS and other relationships with multiple companies. Several co-authors are BMS employees.

Source: Gettinger S et al. J Clin Oncol. 2018 Mar 23 doi: 10.1200/JCO.2017.77.0412.


 

FROM JOURNAL OF CLINICAL ONCOLOGY

Some patients with previously treated advanced non-small cell lung cancer (NSCLC), a malignancy with a historically dim prognosis, survived at least 5 years after receiving the immune checkpoint inhibitor nivolumab (Opdivo) in an early phase 1 trial.

For 129 patients with NSCLC treated with nivolumab in the CA209-003 trial, the estimated 5 year overall survival (OS) was 16%. Twelve patients who did not receive any subsequent therapy following completion of nivolumab were alive with no evidence of disease at the 5-year follow-up mark, reported Scott Gettinger, MD, of the Yale Cancer Center in New Haven, Connecticut, and colleagues.

“Considering the historically low 5-year survival rate for patients with metastatic lung cancer, the estimated 5-year OS rate of 16% from the time of nivolumab treatment initiation observed in this cohort of heavily pretreated patients with advanced NSCLC constitutes a milestone in the advancement of lung cancer treatment,” they wrote in the Journal of Clinical Oncology. In the NSCLC cohort of the phase 1 dose-escalation and expansion study, 129 patients with heavily pretreated advanced NSCLC received nivolumab in doses of 1, 3, or 10 mg/kg intravenously once every 2 weeks in 8-week cycles for up to 96 weeks. The investigators previously reportedthat after a median follow-up of 39 weeks, the median overall survival across all three dose groups was 9.9 months. For 37 patients treated at the 3 mg/kg dose chosen for further development, the median 1-, 2-, and 3-year OS rates were 56%, 42%, and 27%, respectively.

In the current study, they followed the patients out to a minimum of 58.25 months. The median OS was 9.9 months, and the estimated 5-year OS rate, as noted before, was 16%. The 5-year OS rates for patients with squamous histology cancers was 16%, and the rate for patients with nonsquamous histology was 15%.

In all, 16 patients survived at least 5 years, with the longest follow-up out to 88.6 months. Two of the patients died before the database lock in November 2016, one from disease progression, and one from chronic obstructive pulmonary disease.

Among 10 long-term survivors who had quantifiable expression of the programmed death-1 ligand 1 (PD-L1), seven had at least 1% PD-L1 expression at baseline.

Of the 16 5-year survivors, 12 (75%) had a partial response to nivolumab according to RECIST (Response Evaluation Criteria in Solid Tumors), version 1. Two others had stable disease, and two had disease progression at the best response.

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