The United Kingdom’s Medicines and Healthcare Products Regulatory Agency has accepted a marketing authorization application seeking approval for sugemalimab plus chemotherapy as first-line treatment for patients with metastatic non–small cell lung cancer.
The United Kingdom’s Medicines and Healthcare Products Regulatory Agency has accepted a marketing authorization application (MAA) seeking approval for sugemalimab plus chemotherapy as first-line treatment for patients with metastatic non–small cell lung cancer (NSCLC). Drug maker EQRx announced the move in a news release December 19, 2022.1
The UK granted an Innovation Passport designation to the PD-L1 antibody through the Innovative Licensing and Access Pathway (ILAP) in 2021. The ILAP was established in early 2021 to accelerate the development of and access to medicines in the UK.
“With the acceptance of this application, we now have two investigational therapies under review with the MHRA in non-small cell lung cancer, which affects about 40,000 people annually in the U.K. and is a leading cause of cancer death,” Melanie Nallicheri, EQRx president and chief executive officer, said in a news release. “This significant milestone is a step toward our goal of getting our medicines to patients and delivering on our mission of increasing access to impactful treatments.”
The application is based on findings from the phase 3 GEMSTONE-302 trial (NCT03789604). In findings published in The Lancet Oncology, sugemalimab plus chemotherapy improved overall survival (OS) vs placebo plus chemotherapy in patients with newly diagnosed metastatic NSCLC irrespective of PD-L1 expression or tumor histology. The trial met its primary end point of investigator-assessed progression-free survival (PFS) with significantly longer PFS in the sugemalimab arm compared with placebo at a median of 7.8 months (95% CI, 6.9-9.0) vs 4.9 months (95% CI, 4.7-5), respectively (HR, 0.50; 95% CI, 0.39-0.64; P < .0001).2
In final data presented at the 2022 ASCO Annual Meeting, investigators concluded that the sugemalimab plus chemotherapy combination maintained the median PFS benefit, at 9 months (95% CI, 7.4-10.9) vs 4.9 months at a median follow-up of 17.8 months (95% CI, 4.8-5.2; HR, 0.49; 95% CI, 0.40-0.61; P <.0001). Moreover, the 2-year PFS rate was also higher in the sugemalimab plus chemotherapy group at 20.8% compared with 7.3% in the placebo group.3
In the interim analysis, the median OS in the sugemalimab arm was 25.4 months (95% CI, 20.1-not reached) compared with 16.9 months (95% CI, 12.8-20.7) in the placebo group (HR, 0.65; 95% CI, 0.50-0.84; P = .0008). This OS benefit also extended to the 2-year OS rate at 51.7% in the treatment arm vs 35.6% in the placebo arm.
All subgroups observed in the study had OS benefits irrespective of their tumor pathology. For example, 129 patients with squamous cell NSCLC on sugemalimab plus chemotherapy had a median OS of 23.3 months compared with 12.2 months for the 63 patients on placebo plus chemotherapy (HR, 0.56; 95% CI, 0.38-0.82). Similar results were then observed in the nonsquamous subgroup on the trial with a median OS of 26.9 months for 191 patients on the treatment arm vs 19.8 months for the 96 patients on the placebo arm (HR, 0.72; 95% CI, 0.51-1.01).
Patients also had improved OS regardless of their PD-L1 tumor proportion scores. Those with PD-L1 expression levels 1% or greater had a median OS of 27 months in the investigational group vs 19 months (HR, 0.64; 95% CI, 0.46-0.91) in the placebo group and patients with less than 1% of expression had a median OS of 19.4 months vs 14.8 months, respectively (HR, 0.66; 95% CI, 0.45-0.97).
PFS in both groups was improved as well at a median of 10.9 months in the sugemalimab group vs 4.9 months in the placebo group of patients with a PD-L1 expression level of 1% or more (HR, 0.48; 95% CI, 0.36-0.63; P < .0001), and 7.4 vs 4.9 months for patients with less than 1% expression, respectively (HR, 0.57; 95% CI, 0.41-0.78; nominal P = .0005).
The overall response rate (ORR) and duration of response (DOR) were also longer in the sugemalimab arms, researchers found. In the intention-to-treat population, ORR was 63.4% in the sugemalimab arm vs 40.3% in the placebo arm (P < .0001) and median DOR was 9.9 months (range, 0.7-31.5) in the sugemalimab arm vs a median of 4.4 months (range, 0+ to 26.0+) in the placebo arm.