Pembrolizumab (Keytruda) for adjuvant. maintenance use in non-small lung cancer – pro
Randomized and non-randomized clinical trials with a significant number of subjects may be a basis for supportive clinical evidence for determining accepted uses of drugs. If there are no randomized and/or non-randomized clinical trials, then controlled retrospective studies and case series may also be a basis for supportive clinical evidence for determining accepted uses of drugs. Single case reports do not constitute supportive clinical evidence.
The role of maintenance systemic therapy in the treatment of patients with advanced non–small-cell lung cancer (NSCLC) has been a subject of debate for decades. Before the discovery of checkpoint inhibitors (CPIs), the role of maintenance chemotherapy was extensively studied with very modest improvements in survival at the cost of increased toxicity. The most compelling evidence for maintenance chemotherapy showed that continuation of pemetrexed after four cycles of platinum plus pemetrexed combination therapy conferred a survival advantage in patients with advanced nonsquamous NSCLC.
Most studies had been with nivolumab. Although the results from Checkmate 153 have shown that patients who continue nivolumab beyond 1 year have improved survival, there is also evidence that some patients may achieve long-term disease control with minimal exposure to CPIs.
KEYNOTE-010 evaluated the efficacy of pembrolizumab (for up to 2 years) versus docetaxel in the second-line setting in patients with advanced NSCLC. At a median follow-up of 42.6 months, the median duration of treatment in the pembrolizumab arm was 3.5 months (range, 1 day to 31.7 months) and 5.9% of patients discontinued pembrolizumab because of AEs. Data from KEYNOTE-024 established the role of pembrolizumab in the first-line setting in patients with advanced NSCLC with a PD-L1 tumor proportion score ≥ 50% (score not provided in this case).
Two drug regulatory bodies, the European Medicines Agency (EMEA) and the Federal Drug Authority (FDA), have approved pemetrexed as maintenance chemotherapy in nonsquamous NSCLC. KEYTRUDA, as a single agent, is indicated for adjuvant treatment following resection and platinum-based chemotherapy for adult patients with stage IB (T2a ≥4 cm), II, or IIIA non–small cell lung cancer (NSCLC).
N. Shukla et al, Optimal Duration of Maintenance Checkpoint Inhibitor Therapy in Patients With Advanced NSCLC. JCO Oncology Practice 17, no. 8 (August 01, 2021) 472-474.
Keytruda Prescribing Information 2023
NCCN NSCLC 2023