What Attributes Will Distinguish Emerging Therapies, According to Physicians and Payers?
Targeted therapies, particularly tyrosine kinase inhibitors (TKIs) that target angiogenesis, dominate the treatment of advanced/metastatic renal cell carcinoma (RCC) in the first line. While mTOR inhibitors such as temsirolimus (Pfizer’s Torisel) have expanded the treatment options for patients in this setting, especially those with poor-prognosis disease, RCC remains incurable, and most first-line patients relapse following treatment. Significant clinical and commercial opportunities remain for new therapies that can provide greater survival benefits than the currently available agents.
Questions Answered in This Report:
- Extending overall survival (OS) and progression-free survival (PFS) are key goals in the treatment of first-line advanced/metastatic RCC. What are the key primary and secondary clinical trial end points with which new therapies are evaluated? How do U.S. and European oncologists weight specific efficacy end points and other drug attributes in their prescribing decisions for first-line advanced/metastatic RCC?
- Sunitinib (Pfizer’s Sutent) is the 2013 major-market sales leader for first-line advanced/metastatic RCC. What weaknesses exist in its profile that would allow emerging therapies to gain a foothold in the market? Have emerging therapies demonstrated potential on the attributes that surveyed oncologists indicate are the most important in their prescribing decisions? Which emerging therapies will offer the clinical improvements over currently available therapies that surveyed MCO PDs seek from new therapies?
- OS and PFS are key drivers of physicians’ prescribing decisions and/or are the focus of drug development for new first-line advanced/metastatic RCC therapies. What trade-offs (if any) in these and other clinical attributes are U.S. oncologists willing to make when considering the use of emerging therapies for the treatment of first-line advanced/metastatic RCC? Based on the trade-offs in price and performance across key drug attributes that U.S. hematological oncologists are willing to make, how does physician preference and prescribing likelihood vary across different target product profiles for first-line advanced/metastatic RCC?
- By 2023, nivolumab + ipilimumab (Bristol-Myers Squibb/Ono Pharmaceutical’s Opdivo + Bristol-Myers Squibb’s Yervoy) will emerge as the gold-standard therapy in our Drug Comparator Model because of its superior clinical profile over the key current therapies we evaluated. On what clinical attributes is nivolumab + ipilimumab most differentiated from its competitors? Which current therapies are at greatest risk of being replaced by nivolumab + ipilimumab?
Attributes included in conjoint analysis based assessment of target product profiles for first-line advanced/metastatic RCC:
- Median OS.
- Median PFS.
- Overall response rate (ORR).
- All grades neutropenia.
- All grades diarrhea.
- Grade 3/4 fatigue.
Attributes included in assessment of U.S. payers’ receptivity to new therapies for first-line advanced/metastatic RCC:
- Effect on OS.
- Effect on PFS.
- Incidence of all grades neutropenia.
- Incidence of all grades diarrhea.
Physicians surveyed: 60 U.S. and 31 European oncologists.
Payers surveyed: 20 U.S. MCO PDs.
Comprehensive List of Therapies Included in Our Research and Modeling:
- Sunitinib (Pfizer’s Sutent)
- Pazopanib (GlaxoSmithKline’s Votrient)
- Temsirolimus (Pfizer’s Torisel)
- Bevacizumab + interferon-α (IFN-α) (Roche/Genentech/Chugai’s Avastin + Merck & Co.’s Intron A, Roche/Genentech’s Roferon A)
- Sorafenib (Bayer HealthCare/Onyx Pharmaceuticals’ Nexavar)
- Nivolumab + ipilimumab (Bristol-Myers Squibb/Ono Pharmaceutical’s Opdivo + Bristol-Myers Squibb’s Yervoy)
- MPDL-3280A + bevacizumab (Roche/Genentech/Chugai + Roche/Genentech/Chugai’s Avastin)
- Pembrolizumab + pazopanib (Merck & Co.’s Keytruda + GlaxoSmithKline’s Votrient)
- IMA-901 + sunitinib (Immatics Biotechnologies + Pfizer’s Sutent)
- AGS-003 + sunitinib (Argos Therapeutics + Pfizer’s Sutent)