First line nivolumab promising in advanced NSCLC

First line nivolumab promising in advanced NSCLC -

By Shreeya Nanda

results from Phase I published in Journal of Clinical Oncology suggest that nivolumab, either alone or to chemotherapy doublet platinum-based sides, could have a role in the first-line treatment of non-small cell lung cancer (NSCLC).

in the first of two documents, Scott Gettinger (Yale Cancer Center in New Haven, Connecticut, USA) and co-researchers, who report from monotherapy trial CheckMate 012, saying that death 1 anti-programmed antibody has shown a "robust activity" in the first line setting and "an acceptable safety profile."

Among 52 patients with stage IIIB or IV disease not previously treated with chemotherapy, intravenous nivolumab 3 mg / kg every 2 weeks induced a complete response in four and one partial response eight patients during median of 14.3 months of follow up, which is equivalent to an objective response rate of 23%.

researchers say that the responses were durable with a median duration of response not achieved at the time of the analysis, and the majority (75%) occurred in the first assessment of the tumor to the week 11.

progression-free survival (PFS) was a median of 3.6 months and 41% of patients remained progression free at 24 weeks.

Nineteen percent of patients have side effects related to the treatment of Grade 3 or 4 rash with the only event occurring in more than one patient (n = 2), and 12% have abandoned treatment because of associated toxicity.

Although "limited by a highly selected population without randomized to standard chemotherapy," the efficacy results are "expectations far exceed encouraging with chemotherapy alone," conclude Gettinger et al.

In the second document, also based on data CheckMate 012 Naiyer Rizvi, downtown Columbia Medical University in New York, USA, and the team evaluated the addition of nivolumab to standard chemotherapy regimens current used in first-line NSCLC.

The 56 participants, who had stage IIIB or IV NSCLC and had not received chemotherapy for their advanced disease, have been affected by histology nivolumab to receive 10 mg / kg, along with gemcitabine-cisplatin (squamous cell histology), pemetrexed plus cisplatin (squamous cell histology) paclitaxel or carboplatin (all histologies) nivolumab or 5 mg / kg paclitaxel, plus cisplatin (all histologies) for four 21-day cycles. All patients received monotherapy nivolumab after the dual treatment.

Of the 12 patients who received gemcitabine plus cisplatin nivolumab, 33% achieved a response, as 43% of the 14 patients receiving the lower dose of carboplatin plus paclitaxel nivolumab and 47% of 15 participants each nivolumab given 10 mg / kg with pemetrexed-cisplatin or carboplatin paclitaxel.

As seen in patients receiving monotherapy nivolumab, the majority (71%) responses were achieved by week 10 and 42% of responses were underway after a median follow up of 19.0 months , Rizvi et al report.

median PFS times ranged from 4.8 months to 7.1 months, and 24 weeks PFS rates of 38% to 71% in the treatment arm.

in total, grade 3 or 4 adverse events related to treatment were observed in almost half (45%) of participants with pneumonia (7%), fatigue (5%) and renal failure acute (5%) of the most common events. Rizvi and team say that the most common toxicities were as expected with doublet chemotherapy alone, but the dropout rate related toxicity (21%) was higher with the combination.

"Collectively, our results suggest that nivolumab more [platinum-based doublet chemotherapy] may provide benefits beyond chemotherapy alone modality and may be a treatment option for patients with the disease progresses rapidly," conclude -they.

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