Roche (RHHBY) Lung Cancer Drug Gets Positive CHMP Opinion

Roche RHHBY has announced that the European Medicines Agency’s (“EMA”) Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion for Gavreto (pralsetinib).

Gavreto is a once-daily, oral targeted treatment designed to selectively target rearranged during transfection (RET) alterations, including fusions and mutations, regardless of the tissue of origin.

The committee has recommended the approval of the drug as a monotherapy for the treatment of adult patients with RET fusion-positive advanced non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor.

The CHMP recommendation was based on the results of the phase I/II ARROW study wherein Gavreto demonstrated rapid, potent, and durable clinical activity in patients with advanced RET fusion-positive NSCLC.

A final decision regarding the approval of Gavreto is expected from the European Commission in the coming months. Upon approval, the drug will be the first and only targeted treatment approved by the EMA that includes first-line treatment of people with RET fusion-positive advanced NSCLC.

We note that the drug was approved in the United States in September 2020 for the treatment of adults with metastatic RET fusion-positive NSCLC. In December 2020, the FDA approved the drug for another indication — the treatment of adult and pediatric patients 12 years of age and older with advanced RET-altered thyroid cancers.

Roche is co-developing Gavreto with Blueprint Medicines BPMC globally. Both the companies commercialize Gavreto in the United States while Roche enjoys exclusive commercialization rights for Gavreto outside of the United States, except for certain territories in Asia, including China.

RET alterations are key disease drivers in many cancer types, including NSCLC and multiple types of thyroid cancer. Per the company, RET fusion-positive NSCLC affects approximately 37,500 people worldwide each year.

The approval will expand Roche’s portfolio of targeted treatments for NSCLC, which includes drugs like Alecensa (alectinib) and Rozlytrek (entrectinib). These three drugs are likely to offer personalised treatment options for almost one in 10 people with advanced NSCLC.

Shares of Roche have gained 5.1% so far this year compared with the industry’s growth of 8.5%.

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Roche also announced interim data from the phase II coopERA study evaluating neoadjuvant treatment with giredestrant (formerly known as GDC-9545), an investigational next-generation oral selective oestrogen receptor degrader (SERD), in post-menopausal women with ER-positive, HER2-negative early breast cancer at the European Society for Medical Oncology (ESMO) Congress 2021.

Data showed that after 14 days of treatment, giredestrant exhibited a reduction in Ki67, a prognostic marker that measures tumor proliferation compared to anastrozole.  The successful development of new drugs bodes well for Roche as legacy drugs like Herceptin, Avastin, and MabThera face biosimilar competition.

Roche currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the healthcare sector are Regeneron Pharmaceuticals, Inc. REGN and Ironwood Pharmaceuticals IRWD. Both carry a Zacks Rank #1 (Strong Buy).  You can see the complete list of today’s Zacks #1 Rank stocks here.

Regeneron’s earnings estimates have been revised upward  by 17.8% for 2021 and 13.8% for 2022 over the past 60 days. The stock has surged 35% year to date.

Ironwood’s earnings estimates have been revised  upward by 18% for 2021 and 45.7% for 2022 over the past 60 days. The stock has surged 8.5% year to date.

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