SUMMARY
At this year's American Society of Clinical Oncology Conference (ASCO), we will primarily be keeping an eye on Pfizer's PF-2341066, a first-in-class c-Met and ALK inhibitor for non-small-cell lung cancer (NSCLC), the NCI's emerging vaccine gp100, for malignant melanoma, and Novartis and Amgen's bone-resorption inhibitors Zometa and Prolia, for the prevention of bone metastases.  These drugs are all constituents of eagerly-awaited presentations and are sure to be hot topics of discussion at the conference.

ANALYSIS
Vaccines are an emerging therapeutic approach and data expected at ASCO will help to clarify the commercial potential of Provenge.  Presentations on the predictors of outcome by subgroup analysis and correlations between product parameters and overall survival may help prescribers target appropriate populations of patients.  We also eagerly anticipate the presentation of Phase III results at ASCO investigating BMS's ipilimumab and the NCI's DNA vaccine, gp100 in patients with malignant melanoma.

There is much interest in results from the first-in-class c-Met and ALK inhibitor, Pfizer's PF-2341066, to be presented in the plenary session at ASCO. Pfizer announced in September 2009 that PF-2341066, would be progressing directly to Phase III from Phase I for non-small-cell lung cancer (NSCLC).  There is great unmet need for efficacious targeted agents to treat NSCLC: Current treatment options, such as Roche's Avastin and Tarceva have only a modest effect on overall survival (OS) whilst the recent failure of drugs such as AstraZeneca's Zactima and Pfizer's figitumumab means less competition for emerging agents such as PF-2341066. Although PF-2341066 use will be limited to patients with a specific ALK gene translocation, restricting the market to 3-7% of all NSCLC cases, response rates to-date surpass any other response rate we have seen to-date in any NSCLC trial and if the Phase I promise translates to Phase III, use in this niche population will be compelling.

Evidence has emerged that bone-resorption inhibitors such as Novartis Zometa and Amgen's Prolia have therapeutic potential in preventing bone metastases, in addition to a supportive care role in preventing / treating skeletal-related events (SREs).  An MRC-sponsored trial will be presented at ASCO showing that Zometa has a positive impact on overall survival in multiple myeloma.  This result will add credibility to the idea of using bone-resorption inhibitors as a therapeutic treatment option.  Added this to the fact that data will be presented at ASCO positioning Prolia as superior to Zometa for the prevention of SREs in prostate cancer and the landscape is looking rosy for the emerging therapy Prolia.

 

Pivoting a product launch during the pandemic

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