Novartis Announces Data on Tafinlar, Mekinist & Piqray at ESMO

Novartis NVS announced disappointing detailed results from the phase III COMBI-i study at the European Society of Medical Oncology (ESMO) Virtual Congress 2020.

The COMBI-i was a phase III, double-blinded global study (NCT02967692) evaluating the investigational anti-PD1 therapy spartalizumab in combination with Tafinlar + Mekinist compared to Tafinlar + Mekinist and placebo as first-line therapy in patients with unresectable (Stage IIIC) or metastatic (Stage IV) BRAF V600E/K mutation-positive cutaneous melanoma.

While the combination of Tafinlar + Mekinist is approved for the treatment of patients with unresectable or metastatic BRAF-mutated melanoma by the FDA and the European Commission, spartalizumab is an investigational monoclonal antibody directed against the human programmed death-1 (PD-1) receptor.

The trial did not meet its primary endpoint of investigator-assessed progression-free survival (PFS) for patients treated with the investigational triplet therapy.

Nevertheless, Novartis will continue with its spartalizumab development program, evaluating the immunotherapy in combination with other anti-cancer agents.

After having gone through a series of restructuring moves, Novartis looks to strengthen its core pharma business and approval of new therapies will help its cause.

Separately, the company also announced results of the final overall survival (OS) analysis from the SOLAR-1 trial at the ESMO.

The study evaluated breast cancer drug, Piqray (alpelisib), in combination with AstraZeneca’s AZN Faslodex (fulvestrant) compared to Faslodex alone, in hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced breast cancer patients with tumors harboring a PIK3CA mutation.

Data showed that Piqray plus Faslodex demonstrated 8 months of clinically relevant improvement in OS in HR+/HER2- advanced breast cancer (aBC) patients with a PIK3CA mutation compared to Faslodex alone. However, the difference between the arms did not reach the prespecified threshold of statistical significance set for the secondary objective of OS in patients with PIK3CA-mutated breast cancer. A more than 14-month OS improvement was observed in patients with lung or liver metastases, which signify more aggressive disease.

We note that Piqray was approved in July 2020 in combination with Faslodex for the treatment of postmenopausal women, and men, with HR+/HER2- locally advanced or metastatic breast cancer with a PIK3CA mutation after disease progression following endocrine therapy as monotherapy.

The stock has lost 5.8% in the year so far against the industry’s growth of 1.7%.


Solid performance of key drugs like Cosentyx and Entresto and contributions from gene therapy, Zolgensma, have boosted Novartis’ top line but competition is stiff.

Cosentyx maintains a positive momentum for the company on recent label expansions, despite stiff competition from AbbVie’s ABBV Humira and Johnson & Johnson’s JNJ Tremfya.

New launches like Piqray and Beovu too are projected to fuel growth for Novartis.

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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