Thursday, June 7, 2012

ASCO Highlights: Two Innovative Trial Designs

 
The annual scientific meeting for the American Society of Clinical Oncology (ASCO) recently concluded. As expected there was a constant flow of new data being released for products in various stages of development for all forms of cancer. The volume of new data is exciting, even though the decks are stacked against these approaches and their odds for commercial success are slim.

As I scanned articles summarizing data presented at the meeting two studies stood out to me because they have superior efficacy data, but also data on endpoints that answer the question of “value”. These two studies demonstrated bold thinking on the behalf of the companies. First, these companies designed products that are tolerable and don’t take away from patients’ quality of life, which is unheard of for the majority of cancer treatments. Additionally, these companies designed clinical trials to demonstrate efficacy and tolerability, which provides meaningful and valuable data to physicians, payers, and patients.

To proactively seek data to differentiate a product is a risky move. However, this is exactly what payers, physicians, and patients are asking for. We are going to see more of this in the future. The studies also demonstrate the importance of meeting patients’ strong desire for efficacious, tolerable, and safe drugs.

These are tremendous first steps, but in thinking and acting boldly, let’s do more to support patients and caregivers during treatment. We all know the time constraints on healthcare providers, an additional opportunity for life science companies is to provide robust patient and caregiver support programs that educate, inform, and guide patients. Treating cancer is a difficult journey. The more support patients receive the more likely they are to remain on treatment, which dramatically improves their outcomes.

Are you interested in knowing the two studies presented at ASCO that jumped out to me? They are…

1. The study GSK launched in patients with renal cell carcinoma evaluating patient preference for Votrient® (pazopanib) and Sutent® (sunitinib). In the study pazopanib (a late entrant into the market) went head-to-head against sunitinib (the 1st line treatment of choice). Both products have similar efficacy rates. The head-to-head study showed that 70% of patients who completed both treatments prefer pazopanib, 22% of patients that completed both treatments prefer sunitinib, and 8% of patients did not have a preference. The primary reasons patients preferred pazopanib were 1) better quality of life, and 2) less fatigue. This study demonstrates the value of evaluating not only efficacy data, but also patient tolerability preferences too.

2. The Roche/Genentech study with TDM-1, which is the Herceptin® antibody trastuzumab combined with the cytotoxic emtansine. The study of this investigational compound versus Xeloda® (capecitabine) + Tykerb® (lapatinib) in patients with HER2+ relapsed metastatic breast cancer showed a progression-free survival benefit with TDM-1, and lower rates of Grade 3 adverse events (41% versus 57%) and very little gastrointestinal toxicity. This study demonstrates the possibility of developing an efficacious product that has decreased side effects.

I’d like to hear from you. Have you considered, or are planning, a head-to-head trial in order to demonstrate your product's unique differences? Also, what ASCO presentations stood out to you? Please share the studies and why you think these are important trials.

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