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Association details:
| Biomarker: | No biomarker |
|---|---|
| Cancer: | Non Small Cell Lung Cancer |
| Drug: | Cejemly (sugemalimab) (PD-L1 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
CStone and Pfizer announce NMPA approval of sugemalimab in patients with unresectable stage III non-small cell lung cancer
Published date:
06/06/2022
Excerpt:
CStone Pharmaceuticals...announced that the National Medical Products Administration (NMPA) of China has approved sugemalimab (Cejemly®) for the treatment of patients with unresectable stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent or sequential platinum-based chemoradiotherapy.
Source:
Title:
LIGAND’S PARTNER CSTONE PHARMACEUTICALS RECEIVES APPROVAL IN CHINA FOR SUGEMALIMAB (CEJEMLY®) FOR THE FIRST-LINE TREATMENT OF ADVANCED NON-SMALL CELL LUNG CANCER IN COMBINATION WITH CHEMOTHERAPY
Published date:
12/22/2021
Excerpt:
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) today announced that its partner CStone Pharmaceuticals (HKEX: 2616) has received approval from China’s National Medical Products Administration (NMPA) for sugemalimab (Cejemly®), an OmniAb-derived anti-PD-L1 monoclonal antibody, for the first-line treatment of metastatic (stage IV) non-small cell lung cancer (NSCLC) in combination with chemotherapy.
Secondary therapy:
Chemotherapy
Source:
Title:
Interim survival analysis of the randomized phase III GEMSTONE-302 trial: sugemalimab or placebo plus chemotherapy as first-line treatment for metastatic NSCLC
Published date:
06/16/2023
Excerpt:
...prespecified interim OS analysis showed significant improvement with the addition of sugemalimab to chemotherapy (median OS = 25.4 versus 16.9 months; hazard ratio = 0.65; 95% confidence interval = 0.50-0.84; P = 0.0008). Sugemalimab plus chemotherapy provided superior PFS and OS compared to placebo plus chemotherapy, supporting the use of sugemalimab as a first-line treatment option for metastatic NSCLC.
Secondary therapy:
Chemotherapy
DOI:
10.1038/s43018-023-00578-z
Trial ID:
Source:
Title:
A protocol pre-specified interim overall survival (OS) analysis of GEMSTONE-302: A phase 3 study of sugemalimab (suge) versus placebo plus platinum-based chemotherapy (chemo) as first-line (1L) treatment for patients (pts) with metastatic non–small cell lung cancer (NSCLC).
Published date:
05/26/2022
Excerpt:
ORR was 63.4% vs 40.3% (p < 0.0001). Among pts with baseline brain metastases, suge+chemo improved their OS (HR = 0.45) and intracranial INV-PFS (post-hoc analysis, HR = 0.33) vs placebo+chemo….Suge plus chemo demonstrated statistically significant and clinically meaningful OS improvement compared with placebo plus chemo, irrespective of tumor histology or PD-L1 expression levels, in pts with newly diagnosed metastatic NSCLC, offering a new 1L treatment option for this group of pts.
DOI:
10.1200/JCO.2022.40.16_suppl.9027
Trial ID:
Source:
Title:
CStone announces final PFS analysis of a registrational study of sugemalimab in patients with stage III NSCLC further demonstrates its robust efficacy and significant clinical benefits shown in interim analysis
Published date:
05/17/2022
Excerpt:
CStone Pharmaceuticals...announced the pre-planned final PFS analysis results from the registrational GEMSTONE-301 study of sugemalimab as a consolidation therapy in patients with unresectable stage III NSCLC without disease progression after concurrent or sequential chemoradiotherapy. The data showed that sugemalimab maintained a statistically significant and clinically meaningful improvement in PFS as assessed by blinded independent central review (BICR).
Trial ID:
Source:
Title:
Sugemalimab versus placebo, in combination with platinum-based chemotherapy, as first-line treatment of metastatic non-small-cell lung cancer (GEMSTONE-302): interim and final analyses of a double-blind, randomised, phase 3 clinical trial
Published date:
02/23/2022
Excerpt:
At the final analysis (March 15, 2021) with a median follow-up of 17·8 months (IQR 15·1-20·9), the improvement in progression-free survival was maintained (median 9·0 months [95% CI 7·4-10·8] vs 4·9 months [4·8-5·1]; stratified HR 0·48 [95% CI 0·39-0·60], p<0·0001).Sugemalimab plus chemotherapy showed a statistically significant and clinically meaningful progression-free survival improvement compared with placebo plus chemotherapy, in patients with previously untreated squamous and non-squamous metastatic NSCLC, regardless of PD-L1 expression, and could be a newfirst-line treatment option for both squamous and non-squamous metastatic NSCLC.
Secondary therapy:
Chemotherapy
DOI:
10.1016/S1470-2045(21)00650-1
Trial ID:
Source:
Title:
CStone Announces the First-in-Class Registrational Clinical Trial of Sugemalimab Met its Primary Endpoint in Stage III NSCLC and Plans to Submit a New Drug Application
Published date:
05/28/2021
Excerpt:
GEMSTONE-301 study...of the anti-PD-L1 monoclonal antibody sugemalimab in patients with stage III NSCLC met its primary endpoint at a planned interim analysis reviewed by the independent Data Monitoring Committee (iDMC). The findings showed that sugemalimab as a consolidation therapy brought statistically significant and clinically meaningful improvement in the Blinded Independent Central Review (BICR) assessed PFS in patients with locally advanced/unresectable NSCLC without disease progression after concurrent or sequential chemoradiotherapy.
Trial ID:
