Novartis’ Skin Cancer Drug Candidate Fails Late-Stage Trial Target

Novartis AG announced on Saturday that its investigational spartalizumab immunotherapy drug combined with Tafinlar and Mekinist therapies failed to meet its primary endpoint in a late-stage trial for the treatment of a type of advanced skin cancer.

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Novartis (NVS) said that the Phase III COMBI-i study evaluating the investigational spartalizumab (PDR001) immunotherapy, in combination with prescription medications Tafinlar and Mekinist, did not meet its primary endpoint of progression-free survival.

The trial was conducted among untreated patients with unresectable or metastatic (stage IV) BRAF V600 mutation-positive cutaneous melanoma, compared to the treatment of Tafinlar and Mekinist alone. Spartalizumab is an investigational monoclonal antibody directed against the human programmed death-1 (PD-1) receptor.

“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,” said Novartis Chief Medical Officer John Tsai. “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.”

Novartis said that together with the COMBI-i study investigators, it will review the data to learn more from the results, which are expected to be submitted for presentation at a future medical meeting. In addition, the Swiss drugmaker said that it will continue to explore new uses for immunotherapy in cancer treatment, including the ongoing development of spartalizumab, across a range of tumor types.

Novartis shares have now recouped a large chunk of their losses from earlier this year but they are still down 8.8% year-to-date. (See Novartis stock analysis on TipRanks)

Still, Edward Jones analyst Ashtyn Evans retains a bullish view on the stock saying that the drugmaker has a diversified portfolio of medications, “with a lot of innovation in cancer development as well, in different areas from Merck: Gene therapy to transfer genetic material into a patient for a cure.”

Evans added that these are “high-price, highly innovative, patient-specific treatments.”