Novartis NVS announced disappointing results from a late-stage study evaluating the investigational immunotherapy, spartalizumab (PDR001), in combination with the targeted therapies, Tafinlar (dabrafenib) and Mekinist (trametinib). COMBI-i was a randomized, double-blind, placebo-controlled phase III study comparing the combination of anti-PD1 spartalizumab with Tafinlar and Mekinist versus the combination of placebo, and Tafinlar and Mekinist.
The study did not meet its primary endpoint of investigator-assessed progression-free survival. The trial was conducted among untreated patients with unresectable (Stage IIIC) or metastatic (Stage IV) BRAF V600 mutation-positive cutaneous melanoma.
The COMBI-i study was conducted in three parts. These results are from part 3 of the study.
Nevertheless, the spartalizumab development program continues investigating the immunotherapy across a range of tumor types in combination with other anti-cancer agents.
The combination of Tafinlar and Mekinist is approved in certain types of skin cancer, like melanoma, and also for non-small cell lung cancer (NSCLC), among others. This combination performed well in the second quarter and boosted performance of the oncology business unit for both indications.
Approval of new drug combinations holds the key for Novartis as it looks to strengthen its core pharma business after a series of restructuring measures.
The stock has lost 8.8% in the year so far against the industry’s growth of 1.8%.
Last month, Novartis’ second-quarter results were hit by the coronavirus pandemic as sales fell short of expectations. Nevertheless, Cosentyx and Entresto gained market share. We note that Cosentyx maintains momentum for the company on recent label expansions, despite stiff competition from AbbVie’s ABBV Humira, and Taltz and Johnson & Johnson’s JNJ Tremfya. However, the FDA recently approved a label update for ophthalmology drug, Beovu, to include additional safety information regarding retinal vasculitis and retinal vascular occlusion. The growth trajectory that Beovu takes up following this label update is yet to be seen.
Meanwhile, Novartis and partner Incyte INCY initiated a phase III study to evaluate the use of Jakavi in combination with standard of care (SoC) compared with SoC alone in COVID-19 infection.
Novartis currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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