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 patients with HER2-positive disease (HER2 overexpressers) and therefore eligible for trastuzumab treatment, and those deemed HER2-negative. Despite the entrance of Herceptin, the outlook for patients with metastatic gastric cancer is bleak, notably for those with HER2-negative disease. Several emerging therapies including agents from novel drug classes are in development for metastatic gastric cancer; and owing to the high levels of unmet need, significant clinical and commercial opportunity exists for therapies that can provide greater survival benefits than current standards of care.
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?
- Improved tumor response and a lower incidence of gastrointestinal toxicity are key areas of unmet need for 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 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?
- Based on its clinical profile, trastuzumab 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 trastuzumab as the future gold standard in 2017 or 2022?
Attributes included in conjoint analysis-based assessment of target product profiles for metastatic gastric cancer:
- Median overall survival (months).
- Median progression-free survival (months).
- Objective response rate (% of patients).
- Incidence of cardiac dysfunction (% of patients).
- Incidence of neutropenia (grade 3/4) (% of patients).
- Incidence of peripheral edema (all grades) (% of patients).
- Price per 21-day cycle.
Attributes included in assessment of U.S. payers’ receptivity to new therapies for metastatic gastric cancer:
- Effect on median overall survival.
- Effect on progression-free survival.
- Effect on incidence of grade ≥ 3 diarrhea.
- Effect on incidence of grade ≥ 3 neutropenia.
Physicians surveyed: 60 U.S. and 30 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)
- Docetaxel (Sanofi’s Taxotere, generics)
- Pertuzumab (Roche/Genentech/Chugai’s Perjeta)
- T-DM1 (Roche/Genentech/Chugai’s Kadcyla)
- Onartuzumab (Roche/Genentech/Chugai)
- Rilotumumab (Amgen/Astellas Pharma)
- Ramucirumab (Eli Lilly/ImClone Systems)