The introduction of the HER2-targeting agent trastuzumab (Roche/Genentech/Chugai’s Herceptin) in 2010 transformed the treatment algorithm for metastatic gastric cancer, segregating the population into those with HER2-positive disease (and, therefore, eligible for trastuzumab treatment) and those deemed HER2-negative. Although physicians report that progress has been made in the treatment of metastatic gastric cancer—, two new drugs have been approved in the United States in the last five years (trastuzumab and ramucirumab [Eli Lilly/ImClone Systems’ Cyramza])—the overall outcome for patients remains bleak. Several therapies, including agents from novel drug classes, are in development for metastatic gastric cancer. Given the substantial unmet need associated with treatment, the clinical and commercial opportunity for therapies that can provide greater survival benefits are significant.
Questions Answered in This Report:
- Delaying disease progression and improving overall survival are key goals in the treatment of metastatic gastric cancer. 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 metastatic gastric cancer?
- Increased overall survival and delayed disease progression and improved tumor response are key areas of unmet need in metastatic gastric cancer, according to the insights of surveyed U.S. and European oncologists. Which therapies in development for metastatic gastric cancer 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 and price are key drivers of physicians’ prescribing decisions and/or are the focus of drug development for new metastatic gastric cancer 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 the treatment of metastatic gastric cancer? 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 metastatic gastric cancer?
- Based on its clinical profile, ramucirumab 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 in development replace ramucirumab as the future gold standard in 2018 or 2023?
Attributes included in conjoint analysis-based assessment of target product profiles for metastatic gastric cancer:
- Median overall survival (months).
- Median progression-free survival (months).
- Overall response rate (% of patients).
- Incidence of cardiac dysfunction (% of patients).
- Incidence of neutropenia (% of patients) (grade 3/4).
- Incidence of fatigue (% of patients) (all grades).
Attributes included in assessment of U.S. payers’ receptivity to new therapies for metastatic gastric cancer:
- Effect on median overall survival.
- Effect on median progression-free survival.
- Effect on incidence of grade ? 3 diarrhea.
- Effect on incidence of all grades of fatigue.
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:
- Trastuzumab (Roche/Genentech/Chugai’s Herceptin)
- Capecitabine (Roche/Chugai’s Xeloda, generics)
- Leucovorin (Pfizer/Takeda’s Elvorine, generics)
- Oxaliplatin (Sanofi’s Eloxatin/Eloxatine, Yakult Honsha’s Elplat, generics)
- Epirubicin (Pfizer’s Ellence/Pharmorubicin/Farmorubicin/Farmorubicina, generics)
- Ramucirumab (Eli Lilly/ImClone Systems’ Cyramza)
- Irinotecan (Pfizer’s Camptosar/Campto, Daiichi Sankyo’s Topotecin, Yakult Honsha’s Campto, generics)
- Pertuzumab (Roche/Genentech/Chugai’s Perjeta)
- T-DM1 (Roche/Genentech/Chugai’s Kadcyla)
- Ramucirumab + paclitaxel (Eli Lilly/ImClone Systems’ Cyramza + Bristol-Myers Squibb’s Taxol, generics)
- Nivolumab (Bristol-Myers Squibb/Ono Pharmaceutical’s Opdivo)
- Telatinib (Eddingpharm)