Shares of ImmunoGen, Inc. (IMGN) plunged 43.7% immediately after the company announced that its partner, Roche (RHHBY), has reported disappointing top-line results from a phase III study (MARIANNE) on their breast cancer treatment, Kadcyla. Kadcyla failed to meet the primary endpoint of the study: progression free survival (PFS). Roche saw its shares fall 6.6% on the news.
The companies are evaluating Kadcyla for the treatment of HER2-positive metastatic breast cancer (mBC).
The international, randomized, multicenter, three-arm phase III study (n =1,095) was conducted to evaluate three HER2-targeted regimens – Kadcyla plus Perjeta, Kadcyla alone and Herceptin plus taxane chemotherapy – in patients who were previously untreated for HER2-positive mBC. Results from the study revealed that both the arms containing Kadcyla failed to demonstrate a significantly better PFS when compared to Herceptin and chemotherapy.
Meanwhile, Roche plans to report data from the phase III study on Kadcyla at an upcoming medical meeting. The company also intends to work on the data with regulatory authorities.
We note that Roche’s Kadcyla, which utilizes Immunogen’s antibody-drug conjugate (ADC) technology, is currently approved for the treatment of patients with HER2-positive mBC who were previously treated with Herceptin and a taxane.
Immunogen mentioned in its press release that Roche has several other studies on Kadcyla in progress including indications like gastric cancer among others. Roche intends to present data on Kadcyla from the GATSBY study on gastric cancer in 2015, which if found positive would enable the company to file marketing application for the candidate.
Immunogen also informed that the results would not affect the company’s 2015 guidance. The company expects fiscal 2015 total revenues in the range of $100 million to $105 million. The Zacks Consensus Estimate for revenues currently stands at $102 million, which is within the guided range. We remind investors that Immunogen receives and recognizes royalties on sales of Kadcyla under an agreement with Roche entered into in May 2000.
ImmunoGen currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Biodel Inc. (BIOD) and Lannett Company, Inc. (LCI). Both carry a Zacks Rank #1 (Strong Buy).
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