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August 24, 2020

Novartis’ spartalizumab misses primary goal in melanoma study

Novartis has reported data from the Phase III COMBI-i clinical trial of spartalizumab (PDR001) in combination with Tafinlar (dabrafenib) and Mekinist (trametinib) to treat cutaneous melanoma.

Novartis has reported data from the Phase III COMBI-i clinical trial of spartalizumab (PDR001) in combination with Tafinlar (dabrafenib) and Mekinist (trametinib) to treat cutaneous melanoma.

The trial compared the combination to Tafinlar plus Mekinist alone in patients with unresectable (Stage IIIC) or metastatic (Stage IV) BRAF V600 mutation-positive cutaneous melanoma.

It failed to meet the primary endpoint of investigator-assessed progression-free survival.

Spartalizumab is an experimental monoclonal antibody that targets the human programmed death-1 (PD-1) receptorIt is being developed as a immunotherapy to treat various tumour types.

Tafinlar and Mekinist are prescription, targeted treatments intended for use in combination for treating melanoma. The medicines are also indicated for other cancers, including thyroid cancer.

COMBI-i was a randomised, double-blind, placebo-controlled trial performed in three parts. It enrolled previously untreated patients.

Novartis Global Drug Development head and chief medical officer John Tsai said: “While the COMBI-i trial did not reach its primary endpoint, the study’s findings give us valuable insights into the role the investigational immunotherapy spartalizumab may play in future cancer therapy combinations and underscore the previously established importance of Tafinlar + Mekinist for these patients.

“Novartis remains committed to melanoma patients through ongoing research, and we continue to deliver the approved combination therapy Tafinlar + Mekinist to patients around the world.”

The company will work with the COMBI-i trial investigators to review the data for gaining additional insights from the results. Novartis will continue to assess spartalizumab in other tumour types.

Earlier this month, Novartis announced positive data from the Phase II ELARA trial of Kymriah (tisagenlecleucel) in patients with relapsed or refractory (r/r) follicular lymphoma (FL).

At the interim analysis, the trial met its primary endpoint of complete response rate (CRR). The drug is said to have shown clinically meaningful benefit on the CRR measure.

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