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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ASCO: Celebrate Successes and Prepare to Support Patients in the Future

The annual scientific meeting for the American Society of Clinical Oncology (ASCO) starts this weekend in Chicago. This meeting is the premier scientific meeting for new clinical data in oncology. Reflecting on this important meeting I’m reminded of the significant advances that have been made in the last 15 years in treating cancer. Several trends fill me with hope for the future, including…

1) Increasing use of oral therapies
2) Molecularly targeted therapies offer decreased side effects versus traditional chemotherapy
3) The possibility that cancer, in many cases, can be treated as a chronic condition with an emphasis on on-going therapy

Cancer treatment is certainly much more effective, manageable, and tolerable than it was 15 years ago. While there are many advances in oncology treatment to celebrate, significant challenges remain including…  

* Patient adherence to treatment—As more oral treatments are used for treating cancer, patients and their caregivers take on a greater role for ensuring treatments are taken regularly and at prescribed doses. With treatments administered in a physician’s office or medical center the nurses see patients regularly and ensure treatments are administered as prescribed and at appropriate times. 

* Changing needs of patients and caregivers—As patients and caregivers take on more responsibility for administering treatments, they are also taking on more responsibility for monitoring and managing side effects to treatment. This can be a frightening responsibility for caregivers and more can be done to support them in this role.  

* Increased costs for treatment—On average targeted therapies cost significantly more than traditional chemotherapeutic agents. The increased cost is an issue for all stakeholders involved in oncology treatment including patients, caregivers, healthcare providers, payers, and life science companies. Patient co-pay and financial assistance programs are critical in helping many patients pay for their treatment.

For life science companies these challenges are significant, and they are also opportunities to engage with patients, caregivers, and healthcare providers. To begin, ensure you…  

* Understand the patient’s treatment journey, and in particular, the barriers they face in remaining adherent and compliant with treatment 

* Develop and implement comprehensive patient support programs that are a resource and guide for patient’s during their treatment journey  

* Inform and educate healthcare providers on the details of patient and caregiver support programs

As a pharmaceutical call center, we provide as-needed call-in support for patients, caregivers, and healthcare providers to answer questions about a product and its side effects, enroll patients in a support program, and connect patients with co-pay assistance resources. Our Medical Advisory Board works with us to design programs focused on meeting the needs of patients, caregivers, and healthcare providers.

I’d like to hear from you. What challenges does your oncology product(s) face? Please join the conversation and share your thoughts, challenges and questions.

I’ll be in Chicago at the ASCO meeting. If you’ll be at ASCO, please send me an e-mail and we’ll schedule a time to get together. I always enjoy learning about the challenges you're facing.

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