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GME751 · 2 trials · 2 indications
Best Overall Response (BOR) of either Complete Response (CR) or Partial Response (PR) up to 9 months according to RECIST 1.1 as assessed by Blinded Central Imaging
The PK similarity (AUC0-42d) of GME751 compared with pembrolizumab will be demonstrated in subjects with advanced melanoma in the adjuvant setting.
The PK similarity (AUCtau\_ss) of GME751 compared with pembrolizumab will be demonstrated in subjects with advanced melanoma in the adjuvant setting.
| Arm | Type | Description |
|---|---|---|
| GME751 + pemetrexed + carboplatin or cisplatin | EXPERIMENTAL | Participants will receive GME751 + pemetrexed + carboplatin or cisplatin via intravenous (IV) infusion. |
| Keytruda-EU + pemetrexed + carboplatin or cisplatin | ACTIVE_COMPARATOR | Participants will receive Keytruda-EU + pemetrexed + carboplatin or cisplatin via intravenous (IV) infusion. |
| GME751 | EXPERIMENTAL | Subjects will receive GME751 via intravenous (IV) infusion. |
| Keytruda - EU | ACTIVE_COMPARATOR | Subjects will receive Keytruda-EU via intravenous (IV) infusion. |
| Keytruda - US | ACTIVE_COMPARATOR | Subjects will receive Keytruda-US via intravenous (IV) infusion. |
| Name | Type | Description |
|---|---|---|
| GME751 | DRUG | Drug: GME751 Concentrate for solution for infusion, Biologic, Liquid in vial, 100 mg, 200 mg every 3 weeks, i.v. infusion Drug: Pemetrexed (i.v. infusion) Drug: Carboplatin or Cisplatin (i.v. infusion) |
| Keytruda-EU | DRUG | Drug: Keytruda-EU Concentrate for solution for infusion, biologic, liquid in vial, 100 mg, 200mg every 3 weeks, i.v. infusion Drug: Pemetrexed (i.v. infusion) Drug: Carboplatin or Cisplatin (i.v. infusion) |
| Keytruda - EU | DRUG | 400 mg Q6W, i.v. infusion, over 24 weeks period |
| Keytruda - US | DRUG | 400 mg Q6W, i.v. infusion, over 24 weeks period |
Inclusion Criteria: * At least 18 years of age * Untreated metastatic NSCLC * Absence of tumor activating EGFR mutations and absence of ALK gene rearrangements * Measurable disease according to RECIST 1.1 * Adequate organ function * Eastern Cooperative Oncology Group (ECOG) performance status score...
GME751 is an investigational biosimilar to pembrolizumab (Keytruda) being developed for use in melanoma and metastatic non-small cell lung cancer (NSCLC). It has been studied in patients with Stage II and III melanoma and in adults with untreated metastatic non-squamous NSCLC.
GME751 is being developed by Novartis AG, a global pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The drug is a proposed biosimilar to the reference product pembrolizumab (Keytruda).
GME751 is in clinical development. It has completed a Phase 1 pharmacokinetic study in melanoma and a Phase 3 efficacy and safety study in metastatic NSCLC. Both trials are marked as completed, and the drug remains investigational and not yet approved.
GME751 has been studied in two completed trials. NCT06153238 is a Phase 1 pharmacokinetic study comparing GME751 with US-licensed and EU-authorized Keytruda in Stage II and III melanoma. NCT06159790 is a Phase 3 study comparing GME751 with EU-authorized Keytruda in untreated metastatic non-squamous NSCLC.
GME751 is a proposed biosimilar to pembrolizumab, which is marketed as Keytruda. It is designed to be highly similar to the reference product, but it is not the same drug. Clinical trials have compared GME751 directly with Keytruda to evaluate pharmacokinetics, efficacy, safety, and immunogenicity.