Nektar Therapeutics NKTR announced that its breast cancer candidate, NKTR-102 (etirinotecan pegol), has failed to achieve statistical significance in the phase III BEACON study.
The study evaluated single-agent NKTR-102 in comparison to an active control arm comprising a single chemotherapy agent of physician's choice (TPC) in patients suffering from advanced breast cancer and previously treated with a median of three prior therapies for metastatic disease.
Results from the study revealed that the Hazard Ratio (HR) for survival in patients under NKTR-102 compared to those under the active control arm did not achieve statistical significance. This was also the study’s primary endpoint.
Also, the study revealed that NKTR-102 failed to achieve statistical significance in objective response rate and progression-free survival. However, treatment with NKTR-102 resulted in a 2.1 month improvement in median overall survival over patients under TPC. Moreover, survival benefits were observed in pre-specified subgroups including patients suffering from brain metastases and baseline liver metastases.
Nektar intends to continue to review and analyze the data from the late-stage study. The company intends to explore potential regulatory pathways in the U.S. and Europe. The company had previously planned to file for NKTR-102 in both regions by the end of 2015.
Our Take
We are highly disappointed by the much awaited BEACON study results. These results may keep the candidate from approval. We expect Nektar’s share price to be negatively impacted by the news.
The company has a couple of other late-stage candidates including BAX 855 and NKTR-181. While BAX 855 is filed in the U.S. for the treatment of hemophilia A by partner Baxter BAX, NKTR-181 is being developed for the treatment of chronic pain in a phase III study.
Nektar currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Cytokinetics, Incorporated CYTK and Affymetrix Inc. AFFX. Both stocks carry a Zacks Rank #1 (Strong Buy).
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