Ipilimumab continues to push forward expectations for the treatment of melanoma

Exciting news has emerged from BMS on its anti-CTLA-4 mAb, ipilimumab. The antibody has met its primary endpoint, overall survival, in a study looking at first line treatment of metastatic melanoma. The level of improvement in overall survival has yet to be disclosed. Data will be presented at ASCO this year.

Ipilimumab is currently under review around the world but for patients with later stage disease that has already been treated. Pivotal data from NCT00094653 reported that ipilimumab improved median overall survival by close to four months in those with previously treated melanoma, compared with an experimental therapeutic cancer vaccine, gp100, which has been extensively tested in the disease. Median overall survival for ipilimumab alone was 10.1 months versus 6.4 months for gp100 alone. A US decision on whether to approve ipilimumab based on these data has been set for March.

If given the go-ahead, ilipimumab could become the first new therapy approved for melanoma in more than a decade in the US. EU approval of the product in this indication is also anticipated for this year.

Currently, most melanoma is diagnosed at an early stage, with surgery proving curative in many patients. For advanced disease, current treatment options are inadequate, with only three approved drugs: interferon alpha-2b in the adjuvant setting, and dacarbazine and interleukin-2 for metastatic disease. Most patients are therefore treated in clinical trials.

Approved products for melanoma confer only mediocre response rates with minimal effects on survival, and high levels of toxicity, thus restricting their use to certain patients. Unmet needs therefore prevail, highlighting the urgent need to develop novel therapeutics offering significant clinical improvements over existing treatment options.

Depending on the final first line data it is inevitable that BMS will file for a first line indication.

The possibility of filing as a first line therapy has led to share prices peaking at an increase of 6% and Credit Suisse analysts raising their expectations for the drug. A proce of $30,000 per patient per year had been placed on ipilimumab but analysts predict that a first line indication could double this figure leading to peak global ipilimumab sales of in excess of $2 billion.

For further reading on the melanoma market see:

Stakeholder Opinions: Melanoma

Melanoma - Drug Pipeline Analysis and Market Forecasts to 2015