In a late-breaking presentation on Saturday, EQRx and partner CStone Pharmaceuticals will report data from the phase III GEMSTONE-301 study of its anti-PD-L1 antibody sugemalimab.
Non-small cell lung cancer (NSCLC) is one of the most devestating diagnoses and highest unmet needs in the oncology space. EQRx, which intends to solve pricing and access challenges for patients, will unveil new data at the European Society for Medical Oncology (ESMO) Congress 2021 showing that it might just have the answer to NSCLC too.
EQRx was founded on the principle of delivering important new medicines to patients at radically lower prices.
“The PD(L)1 market is becoming more crowded, but the constant debate around pricing without action is to the detriment of patients,” stated Alexis Borisy, EQRx’s executive chairman, board of directors. “PD(L)1 therapies are the backbone of cancer treatment, and we see tremendous opportunity for sugemalimab as a monotherapy or in combination regimens, lowering the overall costs of immunotherapy options.”
In a late-breaking presentation on Saturday, EQRx and partner CStone Pharmaceuticals will report data from the phase III GEMSTONE-301 study of its anti-PD-L1 antibody sugemalimab. The trial is assessing the safety and efficacy of anti-PD-1 checkpoint inhibitor sugemalimab as a consolidation therapy for patients with locally advanced/unresectable Stage III NSCLC without disease progression after concurrent or sequential chemoradiotherapy.
In May, the cross-continental partners (C-Stone is based in Suzhou, China) announced that the study met its primary endpoint of prolonged progression-free survival (PFS), demonstrating statistically significant and clinically meaningful improvement. Patients treated with sugemalimab experienced 9 months of PFS compared with 5.8 months for the placebo group. Patients who received prior concurrent chemoradiotherapy did even better, with 10.5 months of PFS compared to just 6.4 months for those who did not.
The median overall survival (OS) rate was 24.1 months for the placebo group, while OS for the group treated with sugemalimab still had not been met.
The data represent the first positive results from a trial of a PD-(L)1 agent in this population. In this trial of firsts, Sugemalimab is also the world’s first anti-PD-1/PD-L1 monoclonal antibody covering two high unmet need patient cohorts: locally advanced/unresectable (stage III) and metastatic (stage IV) NSCLC.
“GEMSTONE-301 is a unique trial in that it enrolled a highly heterogeneous population of patients with Stage III NSCLC reflective of everyday practice across a range of tumor pathologic subtypes, performance status and those treated with either sequential or concurrent chemoradiotherapy,” said Dr.Vincent Miller, physician-in-chief at EQRx.
In October 2020, CStone and EQRx struck up a global strategic collaboration to develop and commercialize sugemalimab and CS1003, another anti-PD-1 checkpoint inhibitor. Under the terms of the agreement, EQRx obtained exclusive commercialization rights to the oncology assets outside of Greater China. All of the clinical trial work for sugemalimab has been conducted by CStone in China.
