Merck KANDLELIT Trials Spark Hope For Hard-To-Treat Cancers

Merck & Co Inc MRK on Friday shared safety and efficacy results from the open-label Phase 1 KANDLELIT-001 study of MK-1084 alone and in combination with other therapies.

The study included patients with KRAS G12C-mutant solid tumors, advanced colorectal cancer (CRC) and non-small cell lung cancer (NSCLC).

In patients with advanced KRAS G12C-mutated CRC and NSCLC, MK-1084, either as monotherapy or in combinations, demonstrated a manageable safety profile and antitumor activity.

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In CRC, the study assessed MK-1084 as monotherapy, as well as in combination with cetuximab with or without chemotherapy (oxaliplatin and leucovorin plus 5-fluorouracil [mFOLFOX6]). The study evaluated the overall response rate (ORR) in previously treated patients:

• MK-1084 monotherapy (N=53)- Confirmed ORR of 38% and unconfirmed ORR of 43%.
• MK-1084 + cetuximab (N=39)-Confirmed ORR of 46% and unconfirmed ORR of 56%.
• MK-1084 + cetuximab + mFOLFOX6 (N=29)-Confirmed ORR of 38% and unconfirmed ORR of 66%.

In addition to KANDLELIT-001, MK-1084 will be investigated in:

• Phase 3 KANDLELIT-012 study, which is investigating MK-1084 in combination with cetuximab and mFOLFOX6 for the first-line treatment of certain patients with locally advanced unresectable or metastatic CRC who have KRAS G12C-mutated tumors.
• Phase 3 KANDLELIT-004 study, which is investigating MK-1084 in combination with KEYTRUDA for the first-line treatment of certain patients with metastatic NSCLC who have KRAS G12C-mutated tumors and express PD-L1 (TPS ≥50%).

Concurrently, Merck announced results from the dose confirmation portion of the Phase 2/3 waveLINE-003 study of zilovertamab vedotin in combination with standard-of-care rituximab and gemcitabine-oxaliplatin (R-GemOx) for relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

At a pre-planned analysis, zilovertamab vedotin 1.75 mg/kg in combination with R-GemOx achieved a 56.3% objective response rate (ORR) in patients with relapsed or refractory DLBCL (n=16), with eight complete responses (CR) and one partial response (PR).

At a median follow-up of 18.1 months in patients receiving the 1.5 mg/kg dose of zilovertamab vedotin (n=15), ORR was 26.7% (3 CR [20.0%], 1 PR [6.7%]) and median DOR was 14.4 months.

At a median follow-up of 9.3 months for patients receiving the 2.0 mg/kg dose (n=7), the ORR was 57.1% (3 CR [42.9%], 1 PR [14.3%]) and median DOR was not reached.

Seven dose-limiting toxicities occurred across all participants.

Based on these results and accompanying safety data, the recommended Phase 2 dose of zilovertamab vedotin was determined to be 1.75 mg/kg when used with R-GemOx.

Price Action: MRK stock is up 1.09% at $77.24 at the last check on Friday.

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