Curtain Closes on ASCO: 2010's Few Winners

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The Burrill Report submits:

By Peter Winter

In previous years, shares in biotech and pharmaceutical companies have routinely jumped on the release of positive research results at the American Society of Clinical Oncology annual meeting. Now that the curtain has closed on the 2010 event, held in Chicago June 4-8, it is clear (see table below) that the "ASCO-effect" was operating in reverse this year.

The volatile capital markets had a great deal of influence on the share prices of biotech companies this time around, plus many of the companies listed saw their share values move higher in the run-up to the meeting. During the event, trading volume for these companies was at least four to five times normal and, as a result, prices adjusted to post-ASCO selling.

Bristol-Myers Squibb ( BMY ) and Celgene's ( CELG ) presentations stood out among the dizzying array of data offered. Bristol-Myers Squibb reported on a study of its experimental drug ipilimumab, a monoclonal antibody against cytotoxic T-lymphocyte antigen 4 (CTLA-4), which showed that the drug was effective at bolstering the immune system of patients with advanced melanoma. On average the trial improved life spans of these patients by about four months. The company plans to file a marketing application with the U.S. Food and Drug Administration later this year. Some analysts have estimated it could have peak annual sales of up to $1 billion.

Physicians gave positive feedback on Celgene's study results, showing its drug Revlimid may have a role as a maintenance drug and as a lymphoma treatment. Early data showed a Revlimid regimen in front-line follicular lymphoma had a 93 percent overall response rate among 30 patients. The drug also showed positive results as a post-transplant drug in myeloma patients. Treatment with a maintenance regimen of Revlimid resulted in a 58 percent reduction in the risk of tumor progression compared to placebo.

The median time to progression in the placebo arm was 25.5 months, while median time to progression in the Revlimid arm has not yet been reached. In a separate but similar study also looking at Revlimid maintenance in multiple myeloma patients, Revlimid treatment resulted in a 54 percent reduction in the risk of tumor progression compared to placebo. Revlimid is approved as a treatment for multiple myeloma in patients who have been treated with at least one other therapy.




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Results Presented

Ariad Pharmaceuticals





Presented data from an ongoing phase 1 study of its pan-BCR-ABL inhibitor, AP24534, in patients with resistant and refractory chronic myeloid leukemia. The data confirm strong clinical evidence of hematologic, cytogenetic and molecular anti-leukemia activity of AP24534, a multi-targeted kinase inhibitor.






The company's potential lung cancer drug did not meet a key goal in a mid-stage study, but results show it may benefit a sub-group of patients. A combination of its drug ARQ-197 and Tarceva demonstrated a 66 percent improvement in extending survival rates without the cancer progressing. The result fell short when comparing the combination with results in patients taking only Tarceva.

Bristol-Myers Squibb





The company's ipilimumab earned praise for its promising data on melanoma. In a small trial, patients taking the drug lived a median of 10 months, compared to 6.4 months in a control group.






The company's multiple myeloma drug Revlimid showed that when taken as maintenance therapy following stem-cell transplantation, it reduced the risk of disease progression more than 50 percent.

Celldex Therapeutics





Potential skin cancer treatment met key mid-stage study goals. CDX-011 prompted an overall response rate of 15 percent in the 34-patient study. The drug was administered at a "predefined dose" once every three weeks. The company said the results warrant further development of the drug.

Delcath Systems





Treatment with the Percutaneous Hepatic Perfusion (( PHP )) system delayed the time before liver tumors started to grow or death by 6.5 months compared to patients treated with best alternative care.

Keryx Biopharmaceuticals





Reported final results for KRX-0401 (perifosine), the company's oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, in combination with capecitabine as a treatment for advanced, metastatic colorectal cancer.

Nektar Therapeutics





About 48 percent of women with advanced ovarian cancer saw sustained benefits from treatment with experimental drug NKTR-102 in a mid-stage study.






Lung cancer drug crizotinib stopped disease progression in 87 percent of the patients it was tested on. Researchers also tracked a reduction in tumor size among more than half of the patients.






The results from an early stage trial of an experimental drug for non-Hodgkin's lymphoma showed about 49 percent of patients responded to it. Two patients have seen their cancer disappear and 15 have had tumor shrinkage.

Provectus Pharmaceuticals





Announced further positive data on the first forty subjects in its phase 2 clinical trial of PV-10 for metastatic melanoma, with an objective response observed in 61 percent of subjects and a mean Progression Free Survival of at least 11.1 months among those subjects achieving an objective response.

Sunesis Pharmaceuticals





Updated data from phase 2 studies of voreloxin in combination with cytarabine in first relapsed or primary refractory acute myeloid leukemia exhibit a meaningful improvement in overall survival relative to literature-based values reported for current treatment standards of care, including cytarabine-based regimens.

YM Bioscience





Reported positive results from several global nimotuzumab trials in adults with Glioblastoma Multiforma and in patients with head and neck cancer.

ZioPharm Oncology





Presented updated data from a phase 2 PICASSO trial of palifosfamide in patients with soft tissue sarcoma. The updated data demonstrated a statistically significant, 3.4-month, 77 percent improvement in progression free survival, with 7.8 months in the palifosfamide + doxorubicin arm versus 4.4 months in the doxorubicin-alone arm.

See also The Problem With Somaxon's Silenor on

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of The NASDAQ OMX Group, Inc.

This article appears in: Investing , Technology



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