Global Submission Seeks Approval for Sugemalimab Treatment in NSCLC

Global submission seeks approval for sugemalimab treatment in stage 3 non-small cell lung cancer after chemoradiotherapy, supported by phase 3 GEMSTONE-301 study results.

A Type 2 variation application has been submitted to the European Medicines Agency seeking approval for treatment with sugemalimab in patients with unresectable stage 3 non-small cell lung cancer (NSCLC) who have not progressed following concurrent or sequential platinum-based chemoradiotherapy, according to a press release from CStone Pharmaceuticals.

The application is supported by data from the phase 3 GEMSTONE-301 study, a multicenter, randomized, double-blind study. The investigation is evaluating treatment with sugemalimab as consolidation therapy in patients with unresectable stage 3 NSCLC post-chemoradiotherapy.

According to results from the study, which were published in The Lancet Oncology, sugemalimab had a 36% reduction in risk of disease progression or death, significantly improved progression-free survival. Moreover, when utilized in this patient population, sugemalimab led to a 56% reduction in risk of death, with a strong positive trend toward overall survival benefit. There was a consistent clinical benefits across subgroups, regardless of prior chemoradiotherapy modality (concurrent or sequential), as well as a favorable safety profile, no new safety signals identified.

“Following sugemalimab's approval in Europe for stage 4 NSCLC, we are working closely with the European Medicine’s Agency to expand its indications in earlier stage lung cancer and other malignancies” Dr. Jason Yang, chief executive officer and president of R&D, as well as executive director at CStone, stated in the press release. “With its demonstrated outstanding efficacy and safety profile, sugemalimab is poised to address critical unmet needs for [patients with] stage 3 NSCLC. We remain steadfast in expanding global access through strategic partnerships and collaborations with regulatory authorities, ensuring this innovative therapy reaches patients worldwide.”

This is the second regulatory submission for sugemalimab to the European Medicines Agency, according to the release, following its initial European approval in 2024 for metastatic squamous and non-squamous NSCLC. If granted, this new indication would help fill a treatment gap in stage 3 NSCLC, where only one PD-L1 antibody is currently approved in Europe. By demonstrating efficacy in both stage 3 and 4 NSCLC, sugemalimab has the potential to become a foundational immunotherapy option for lung cancer treatment, the release states.

More Information on X and Current Approvals

Sugemalimab is an anti-PD-L1 monoclonal antibody and is a fully human, full-length immunoglobulin G4 monoclonal antibody. The agent was developed CStone by utilizing the OmniRat transgenic animal platform, which allows creation of fully human antibodies in one step, according to the news release. The agent, due to its mechanism of action and makeup, may reduce the risk of immunogenicity and toxicity for patients. In turn, according to the release, this offers a unique advantage over similar drugs.

For the patients with metastatic NSCLC with no sensitizing EGFR mutations, or ALK, ROS1 or RET genomic tumor aberrations, first-line treatment with sugemalimab has been approved by both the European Commission as well as the Medicines and Healthcare products Regulatory Agency in combination with platinum-based chemotherapy.

Additionally, sugemalimab is approved for five indications by The National Medical Products Administration of China.

These approvals include sugemalimab plus chemotherapy in the first-line treatment of patients with metastatic squamous and non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations and metastatic squamous NSCLC; the treatment of patients with unresectable Stage III NSCLC whose disease has not progressed following concurrent or sequential platinum-based chemoradiotherapy; for the treatment of patients with relapsed or refractory extranodal T-cell lymphoma; sugemalimab in combination with fluorouracil and platinum-based chemotherapy for the first-line treatment of patients with unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma; and sugemalimab in combination with fluoropyrimidine- and platinum-containing chemotherapy as first-line treatment for unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma with a PD-L1 expression combined positive score of 5 or greater.

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