Will the Emerging Immunotherapies and BRAF/MEK Inhibitor Combinations Meet Physicians’ and Payers’ Expectations?
In recent years, several new, high-priced therapies have been approved for use in first-line unresectable/metastatic malignant melanoma, making this relatively small market more dynamic and competitive. The launch of these agents has significantly altered the treatment algorithm and improved the outlook for patients; nevertheless, our research indicates that significant clinical and commercial opportunity remains for therapies that can further prolong overall survival (OS). Several therapies are in late-stage development for first-line unresectable/metastatic malignant melanoma, all of which are showing considerable potential for improving efficacy outcomes in this indication.
Questions Answered in This Report:
- Extending OS and progression-free survival (PFS) are key goals in the treatment of first-line unresectable/metastatic malignant melanoma. 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 unresectable/metastatic malignant melanoma?
- Increased OS, delayed disease progression, and a lower rate of immune-related adverse events are key areas of unmet need for first-line unresectable/metastatic malignant melanoma according to the insights of surveyed U.S. and European oncologists. Which therapies in development for first-line unresectable/metastatic malignant melanoma are poised to fulfill these needs? What clinical and/or regulatory challenges must drug developers overcome in order to capitalize on these areas of unmet need? What degree of improvement over currently available therapies do surveyed U.S. MCO PDs seek from new therapies on key clinical attributes for which surveyed physicians indicate there is high unmet need?
- Median overall survival (MOS) and PFS are key drivers of physicians’ prescribing decisions and are the focus of drug development for new first-line unresectable/metastatic malignant melanoma therapies. What trade-offs across these and other clinical attributes are U.S. oncologists willing to make when considering the use of emerging therapies for first-line unresectable/metastatic malignant melanoma? Based on the trade-offs in price and performance across key drug attributes that U.S. oncologists are willing to make, how do physician preference and prescribing likelihood vary across different target product profiles for first-line unresectable/metastatic malignant melanoma?
- Based on its clinical profile, vemurafenib (Roche/Genentech/Daiichi Sankyo/Chugai’s Zelboraf) is the current clinical gold standard in our Drug Comparator Model. What attributes do thought leaders believe differentiate this therapy from competing current therapies and emerging therapies? Will any therapies challenge vemurafenib as the future gold standard in 2018 or 2023?
Attributes included in conjoint analysis-based assessment of target product profiles for first-line unresectable/metastatic malignant melanoma:
- Median overall survival (months)
- Median progression-free survival (months)
- Objective response rate (% of patients)
- Rate of diarrhea (all grades) (% of patients)
- Rate of rash (all grades) (% of patients)
- Rate of fatigue (all grades) (% of patients)
- Price per course of treatment
Attributes included in assessment of U.S. payers’ receptivity to new therapies for first-line unresectable/metastatic malignant melanoma:
- Effect on overall survival
- Effect on progression-free survival
- Effect on objective response rate
- Effect on all grades of diarrhea and nausea
Physicians surveyed: 61 U.S. and 31 European oncologists.
Payers surveyed: 20 U.S. MCO PDs.
Comprehensive List of Therapies Included in Our Research and Modeling:
- Ipilimumab (Bristol-Myers Squibb’s Yervoy)
- Dacarbazine (Bayer HealthCare’s DTIC-Dome, generics)
- Temozolomide (Merck & Co.’s Temodar/Temodal, generics)
- Interleukin-2 (Prometheus/Novartis’s Proleukin/Macrolin)
- Vemurafenib (Roche/Genentech/Daiichi Sankyo/Chugai’s Zelboraf)
- Nivolumab (Bristol-Myers Squibb’s Opdivo)
- Pembrolizumab (Merck & Co.’s Keytruda)
- Nivolumab (Bristol-Myers Squibb’s Opdivo) + ipilimumab (Bristol-Myers Squibb’s Yervoy)
- Dabrafenib (Novartis’s Tafinlar) + trametinib (Novartis’s Mekinist)
- Vemurafenib (Roche/Genentech/Daiichi Sankyo/Chugai’s Zelboraf) + cobimetinib (Roche/Genentech/Exelixis)