Benzinga | Jan 18, 2022 08:22AM EST

EQRx Reports 2 Lancet Oncology Publications Post Phase 3 Results Of Sugemalimab In Stage 3, 4 Non-Small Cell Lung Cancer

Results from the pivotal Phase 3 GEMSTONE-301 study demonstrated that sugemalimab, an anti-PD-L1 antibody, improves progression-free survival (PFS) in patients with Stage III non-small cell lung cancer (NSCLC) after sequential or concurrent chemoradiotherapy

Concurrently published results from the pivotal Phase 3 GEMSTONE-302 study demonstrated PFS benefit with sugemalimab plus chemotherapy in first-line systemic treatment of patients with Stage IV NSCLC, regardless of tumor pathologic subtype or PD-L1 expression levels

Data reinforce the potential of sugemalimab for the treatment of this broad range of patients with NSCLC

CAMBRIDGE, Mass., Jan. 18, 2022 (GLOBE NEWSWIRE) -- EQRx, Inc. (NASDAQ:EQRX) a new type of pharmaceutical company committed to developing and delivering important new medicines to patients at radically lower prices, today announced that data from its partner CStone Pharmaceuticals' two pivotal Phase 3 studies of the anti-PD-L1 monoclonal antibody sugemalimab for the treatment of non-small cell lung cancer (NSCLC), GEMSTONE-301 and GEMSTONE-302, were published in The Lancet Oncology. The publications were accompanied by a comment article.

In GEMSTONE-301, sugemalimab resulted in a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus placebo when administered as consolidation therapy in patients with locally advanced, unresectable Stage III NSCLC without disease progression after concurrent or sequential chemoradiotherapy. This represents the first positive Phase 3 data for an anti-PD-L1 agent in this broader population of patients with Stage III NSCLC.1

In GEMSTONE-302, the addition of sugemalimab to standard-of-care chemotherapy as first-line systemic treatment provided a statistically significant, clinically meaningful improvement in PFS in patients with Stage IV NSCLC, regardless of PD-L1 expression levels or pathologic subtype of NSCLC.2

"Taken together, the publication of data from these two Phase 3 studies in The Lancet Oncology adds to a growing body of evidence suggesting that sugemalimab may be a promising option for a wide range of patients with Stage III or Stage IV non-small cell lung cancer upon approval in global regions beyond China," said Vince Miller, MD, physician-in-chief at EQRx. "We look forward to progressing discussions with global regulatory authorities with the goal of bringing a new, high-quality treatment option to these patient populations at a much lower price."

Results from GEMSTONE-301 reported in The Lancet Oncology are as follows:

* Sugemalimab as consolidation therapy demonstrated a statistically significant and clinically meaningful improvement in PFS vs. placebo, as assessed by blinded independent central review (BICR) at a prespecified interim analysis. Median PFS was 9.0 months vs. 5.8 months (Hazard Ratio [HR]=0.64, p=0.0026).

* Clinical benefit was observed in patients who received either concurrent or sequential chemoradiotherapy prior to treatment with sugemalimab compared to placebo. For patients who received prior concurrent chemoradiotherapy (cCRT), median PFS was 10.5 months vs. 6.4 months (HR=0.66). For patients who received prior sequential chemoradiotherapy (sCRT), median PFS was 8.1 months vs. 4.1 months (HR=0.59).

* Overall survival (OS) data were immature at the time of the analysis, but an encouraging trend for a survival benefit with sugemalimab vs. placebo was observed, with follow-up of patients ongoing.

* Sugemalimab was generally well-tolerated, with no new safety signals observed. In the sugemalimab group, 9% of patients (n=22/255) experienced grade 3 or 4 treatment-emergent adverse events (TEAEs) related to study treatment. In the placebo group, 6% (7/126) experienced grade 3 or 4 TEAEs related to study treatment.

Results of the final PFS analysis from GEMSTONE-302, also reported in The Lancet Oncology, are as follows:

* Sugemalimab plus platinum-based chemotherapy significantly prolonged PFS (median 9.0 vs 4.9 months; HR=0.48; p<0.0001) compared with placebo plus platinum-based chemotherapy.

* OS data were immature at the time of the final PFS analysis, but preliminary median OS was 22.8 months in the sugemalimab plus chemotherapy arm compared to 17.7 months in the placebo plus chemotherapy arm (HR=0.67).

* Clinical benefit was observed across all subgroups, regardless of PD-L1 expression level or pathologic subtype of NSCLC.

* Sugemalimab was generally well-tolerated, with no new safety signals observed.

* 53.8% of patients (172/320) in the sugemalimab group and 56.0% (89/159) in the placebo group experienced treatment-related grade 3 or 4 TEAEs, with the most common events for both groups being neutrophil count decrease, white blood cell count decrease, anemia, platelet count decrease and neutropenia.

EQRx's partner, CStone Pharmaceuticals, previously presented results on the use of sugemalimab in the treatment of patients with Stage III and Stage IV NSCLC at ESMO 20213,4 and the IASLC 2021 World Conference on Lung Cancer, respectively.5,6

Sugemalimab is being studied in patients with different stages of NSCLC, in patients with gastric and esophageal cancers and in patients with lymphoma.