Small-cell lung cancer ( SCLC ) is an aggressive lung cancer with high rate of relapse following initial treatment; immunotherapy holds potential as a novel treatment option for this disease.
The anti-PD-L1 antibody Durvalumab ( Imfinzi ) has demonstrated clinical activity with manageable toxicity in several tumor types, including NSCLC.
SCLC expansion cohort of a phase 1/2 study of Durvalumab monotherapy has been reported.
Patients with pretreated extensive disease small-cell lung cancer ( ED-SCLC ), ECOG PS 0-1, regardless of PD-L1 expression, received Durvalumab 10 mg/kg every 2 weeks for up to 12 months.
The primary objective was to determine the safety profile; antitumor activity was evaluated using investigator-assessed RECIST v1.1.
As of 16 October 2017, 21 patients with ED-SCLC ( median age 65.0 years, 62% male, 91% ECOG PS 1, 90% current / former smokers ) were treated with Durvalumab, median 3 cycles, median duration of follow-up 36.4 months ( range 1.4–37.9 ).
20 patients ( 95.2% ) received prior anti-cancer therapy ( median, 2 lines ).
7 patients ( 33.3% ) had treatment-related adverse effects, all were grade 1 or 2; the most common were nausea, fatigue, and rash maculo-papular ( each 9.5% ).
There were no treatment-related adverse effect leading to discontinuation and no treatment-related deaths.
Confirmed objective response rate ( ORR ) was 9.5% ( 2 PR [ partial rate ]; 95% CI 1.2–30.4 ) and disease control rate 24 ( DCR24 ) was 14.3% ( 95% CI 3.0–36.3 ).
Duration of response was 14.6 months for one patient ( treatment-naïve ), and 29.5+ months for the other patient ( Platinum refractory with 3 prior lines of therapy ), who continued to maintain response 25.5 months after completing protocol-defined initial treatment with Durvalumab.
Median progression-free survival ( PFS ) was 1.5 months ( 95% CI 0.9–1.8 ), median overall survival ( OS ) was 4.8 months ( 95% CI 1.3–10.4 ), and 12-month OS rate was 27.6% ( 95% CI 10.2–48.4 ).
In conclusion, consistent with studies in other tumor types and with other anti-PD-1 / PD-L1 therapies, Durvalumab monotherapy has demonstrated durable clinical activity in certain patients with pretreated extensive disease small-cell lung cancer with no new safety signals. ( Xagena )
Source: American Society of Clinical Oncology - ASCO Meeting, 2018