The 2012 Annual Meeting of the American Urological Association, dubbed AUA2012, kicks of May 19 in Atlanta, GA, at the Georgia World Congress Center. Running through May 23, the meeting features more than 100 courses, programs related to urologic research, more than 2,000 presentations, a day of live surgeries, and a host of other activities of importance to the urological community.
Of particular interest to Dendreon (DNDN) investors are two papers to be presented on the corporation's lead immunotherapeutic treatment for end stage prostate cancer (or more formally, asymptomatic or minimally symptomatic metastatic, castration-resistant prostate cancer, or mCRPC). These are presentations found in the program as Abstract 683 and 953.
Abstract 683, to be presented on Sunday, May 20, is the work of L. Gomella, et al, and is entitled "Estimating the overall survival benefit of sipuleucel-T in the IMPACT trial accounting for crossover treatment in control subjects with autologous immunotherapy generated from cyropreserved cells." The work addresses the effect of crossovers in the pivotal IMPACT trial for sipuleucel-T (Provenge) in which control subjects - that is, patients in the placebo cohort - who demonstrated objective disease progression were offered 3 infusions of an autologous cellular therapy (APC8015F) produced from cells frozen at the time of control product generation. An exploratory analysis was performed to estimate how APC8015F impacted the overall survival, or OS, benefit of sipuleucel-T in the IMPACT study. You may recall that I previously addressed this issue here and here. (Recall, too, that the possibility of receiving APC8015F, also known as Frovenge, was offered to patients in the placebo cohort as an inducement to enlist in the trial.)
As noted by the authors, in the IMPACT study (n=512), there was a 4.1-month improvement in median OS (25.8 vs. 21.7months) for sipuleucel-T compared with control (HR=0.78; 95% CI: 0.61, 0.98; p=0.032). Importantly, 109/171 (64%) of control patients received APC8015F. Other post-progression interventions were similar. However, the results of their analyses led them to conclude the following:
"Post-progression treatment with APC8015F may have extended the survival of control subjects in the IMPACT study. Adjusting for use of APC8015F resulted in an increase in median OS benefit with sipuleucel-T of up to 7.8 months. These results suggest a greater treatment effect of sipuleucel-T than reported in IMPACT, and should be factored into future studies without APC8015F crossover." (As I mentioned earlier, in November, 2011, at the Lazard Healthcare Conference, Greg Schiffman, DNDN CFO, mentioned that in 2013, the company will initiate a trial with Provenge in earlier stage prostate cancer, a trial for men who are hormonally sensitive (not castrate resistant, but where the disease has metastasized). In particular, he stressed that the placebo arm in this trial would be a true placebo ... that is, one that did not include frozen Provenge, or Frovenge, as it is known. As such, he said, the company anticipated a much higher overall survival, or OS, advantage than what had been observed in the pivotal Provenge trials.)
In Abstract 953, entitled "Sipuleucel-T in African Americans: a subgroup analysis of three phase 3 trials of sipuleucel-T in metastatic castrate resistant prostate cancer," is by D.G. McLeod, et al. and will be presented on May 21. It addresses an important topic because African American, or AA, men are disproportionately affected by prostate cancer, with an incidence and death rate of 230.0 and 54.2 per 100,000, respectively, vs. 143.8 and 22.8 for Caucasians.
The objectives of the analyses performed were to assess the outcomes and product parameters for AA patients who were treated in the three phase 3 clinical trials of Provenge. The conclusions drawn were as follows: "While no definitive conclusions can be drawn given the limited sample size, the overall survival, or OS, hazard ratio, or HR,* for AA was well below that for the overall population, with a 95% confidence interval bounded below 1, suggesting that AA patients with mCRPC benefit from sipuleucel-T treatment, and providing support for further investigation of the hypothesis that AA may derive a greater benefit from sipuleucel-T. The product parameters and adverse effects profiles for AA are similar to that of the general population studied."
*In survival analysis, the hazard ratio, or HR, is the ratio of the hazard rates corresponding to the conditions described by two sets of explanatory variables. For example, in a drug study, the treated population may die at twice the rate per unit time as the control population. The hazard ratio would be 2, indicating higher hazard of death from the treatment. Or in another study, men receiving the same treatment may suffer a certain complication 10 times more frequently per unit time than women, giving a hazard ratio of 10. (see here).
You are welcome to search for other AUA2012 abstracts here.
The daily chart, courtesy StockChart.com, is below. It shows the issue rising slightly in relative strength and continuing to climb back toward the 50-day moving average following Wall Street's disappointment with the conservative expectations voiced by management on the last conference call.
The weekly chart is more encouraging, showing the stock still rising out of its oversold condition, with the MACD neutral. Interestingly, there is the hint that the price is sitting on the lower boundary of an upwardly trending channel defined by the maximum and minimum price excursions dating back to last July.
Additional disclosure: I am long DNDN and will not alter my position within 72 hours of the time of publication of this article. I am not a registered investment advisor and do not provide specific investment advice. The information contained herein is for informational purposes only. Nothing in this article should be taken as a solicitation to purchase or sell securities. Before buying or selling any stock you should do your own research and reach your own conclusion. It is up to investors to make the correct decision after necessary research. Investing includes risks, including loss of principal.