Eisai Co. Ltd. is taking advantage of Novartis AG's strength in the US oncology sector through a new co-marketing tie-up for the Japanese firm's Lenvima (lenvatinib mesylate) combination in the kidney cancer setting.

Sales reps from both firms will promote the Eisai drug for its newly approved additional indication of advanced renal cell carcinoma (RCC) following one prior anti-angiogenic therapy. Lenvima was cleared by the FDA in mid-May for use in this setting, but only in combination with Novartis's already marketed anticancer agent Afinitor (everolimus).

The two companies said they will provide science-based evidence to physicians and work together on related commercial and medical affairs activities, with each company to continue booking sales of their respective products. Other financial terms of the tie-up were not disclosed.

Eisai noted that there around 58,000 kidney cancer patients in the US, with RCC accounting for around 90% of this total.

Eisai has a well-established commercial presence in the US, with around 1,200 employees in total, and started to build up its cancer business back in 2006, when it acquired four marketed oncology-related products along with a small specialist sales force from Ligand Pharmaceuticals Inc.

But it is now looking to tap into Novartis's much bigger presence in the sector to drive sales of Lenvima, which was first approved in the US in February 2015 (and for the first time globally) for locally recurrent or metastatic, progressive radioactive iodine-refractory differentiated thyroid cancer. [See Deal]

Novartis already has a large oncology portfolio including Afinitor, an mTOR inhibitor broadly approved globally for second-line advanced RCC, second-line advanced HR+/HER2- breast cancer (with exemestane), and advanced neuroendocrine tumors (NETs) of pancreatic origin, and also in the US for advanced NETs of gastrointestinal or lung origin.

The Swiss firm also completed its acquisition of a portfolio of GlaxoSmithKline PLC oncology products in March 2015, further bolstering its presence.

Proven Efficacy

The Lenvima/Afinitor combination is the only such approved therapy to have demonstrated a significant prolongation in progression-free survival (PFS) over standard of care in the RCC setting. The 153-patient Study 205 trial used to support the US approval showed that lenvatinib 18mg plus everolimus 5mg gave a median PFS of 14.6 months, versus 5.5 months for everolimus alone (p=0.0005) and 7.4 months for lenvatinib alone.

The combination also showed improvements in objective response rate and overall survival compared with everolimus alone.

Lenvatinib is an oral multiple receptor tyrosine kinase inhibitor that acts on a number of molecular targets including VEGFR1, 2 and 3, and FGFR1-4, and Eisai is positioning the molecule as one of the pillars of its strategic push into oncology along with Halaven (eribulin), which is already approved for breast cancer initially.

Eisai's other cancer-related products marketed in the US include the anti-emetic agents Aloxi (palonosetron) and Akynzeo (netupitant/palonosetron).

Lenvima is approved in various thyroid cancer settings in around 40 other countries, and a filing seeking approval for RCC in the EU was filed in January. Clinical studies are also underway in several other planned indications including hepatocellular carcinoma (Phase III), endometrial carcinoma, biliary tract cancer, melanoma, and non-small cell lung cancer (all Phase II).

Lenvatinib is also being assessed for potential combination use against solid tumors with the PD-1 immune checkpoint inhibitor pembrolizumab (Merck & Co. Inc.'s Keytruda).

Eisai’s global sales of Lenvima in the fiscal year ended March 31 were a modest JPY11.5bn ($105.5m) - including JPY8.8bn in the Americas region - but are expected to more than double to JPY28bn (JPY19bn in the Americas) this fiscal year.

In a forecast issued before the signing of the Novartis alliance, Datamonitor Healthcare sees US sales of Lenvima for RCC reaching $58.8m in 2024.

Eisai Taps Novartis Oncology Firepower For Lenvima

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