GlaxoSmithKline’s (GSK) shares fell 0.56% after the company announced that it has decided to terminate the phase III MAGRIT study on its MAGE-A3 cancer immunotherapeutic. We note that Glaxo has a collaboration agreement with Agenus Inc. (AGEN) for the candidate. Agenus shares tumbled 3.02% on the news.
The randomized, blinded, placebo-controlled study evaluated the efficacy and safety of the MAGE-A3 cancer immunotherapeutic in patients suffering from stage IB, II and IIIA completely resected non-small cell lung cancer (NSCLC), whose tumors expressed the MAGE-A3 gene. Glaxo decided to stop the study after it was found impossible to identify a sub-population of gene-signature positive NSCLC patients that may benefit from the MAGE-A3 cancer immunotherapeutic.
We remind investors that just a few weeks back, Glaxo had reported disappointing data from this study. The data from the MAGRIT study revealed that MAGE-A3 cancer immunotherapeutic did not significantly extend disease free survival (DFS) in both the overall MAGE-A3 positive population and in MAGE-A3-positive patients who did not receive chemotherapy as compared to placebo. At that time, Glaxo decided to continue with the MAGRIT study to assess the third co-primary endpoint.
We note that MAGE-A3 cancer immunotherapeutic is also being evaluated for stage IIIB/C melanoma with macroscopic nodal disease in patients whose tumors expressed the MAGE-A3 gene and were removed surgically. In Sep 2013, Glaxo had announced that the phase III DERMA study evaluating MAGE-A3 cancer immunotherapeutic in melanoma patients failed to meet its first co-primary endpoint.
The independent data monitoring committee (IDMC) recommended continuation of the DERMA study until its second co-primary endpoint was evaluated. Data related to the second co-primary endpoint is expected in 2015.
With the NSCLC indication off the table and a failed melanoma study, our expectations from the MAGE-A3 cancer immunotherapeutic are at an all-time low.
Glaxo carries a Zacks Rank #4 (Sell). Some better-ranked stocks include Alexion Pharmaceuticals, Inc. (ALXN) and Alkermes (ALKS). Both carry a Zacks Rank #1 (Strong Buy).
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