What Improvements Do Physicians and Payers Expect from Emerging Therapies?

Owing to a lack of specific symptoms, the majority of patients with ovarian cancer (CaO) present at an advanced stage of disease, when the tumor has spread outside the pelvis. Following initial debulking surgery, CaO patients with metastatic involvement are treated with the view of slowing disease progression and extending overall survival (OS). Current drug regimens for first-line advanced CaO include doublet chemotherapy combinations of platinum agents (cisplatin [Bristol-Myers Squibb’s Platinex, generics] or carboplatin [Bristol-Myers Squibb’s Paraplatin, generics]), with either a taxane (paclitaxel [Bristol-Myers Squibb’s Taxol, generics] or docetaxel [Sanofi’s Taxotere, generics]) or pegylated liposomal doxorubicin (PLD; Janssen Biotech’s Doxil/Caelyx). Bevacizumab (Roche/Genentech/Chugai’s Avastin), an inhibitor of vascular endothelial growth factor (VEGF) ligand and an inhibitor of angiogenesis, is the only targeted agent used in the first-line advanced setting for CaO; it is used in combination with chemotherapy and is continued as a monotherapy maintenance treatment. Bevacizumab was approved in Europe in December 2011 for first-line advanced CaO, and although the agent is not approved in the first-line setting in the United States, interviewed experts report off-label use. The emerging therapies considered in the report include targeted agents (i.e., olaparib [AstraZeneca’s Lynparza], trebananib [Amgen/Takeda], and nintedanib [Boehringer Ingelheim’s Vargatef]) and an immunotherapy (Sotio’s DCVAC/OvCa), which are being evaluated in combination with current chemotherapy. Commercial opportunity awaits emerging targeted agents that can provide greater survival benefits than the current standards of care and add minimal toxicities to the existing chemotherapy regimens used to treat first-line advanced CaO.

Questions Answered in This Report:

  • A drug’s performance on median overall survival (MOS) and progression-free survival (PFS) is important for drug approval and physician use. 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 CaO?

  • Increased OS and delayed disease progression are key areas of unmet need for first-line advanced CaO according to the insights of surveyed U.S. and European oncologists. Which therapies in development are poised to fulfill these needs? What degree of improvement over currently available therapies do surveyed U.S. managed care organization pharmacy directors (MCO PDs) seek from new therapies on key clinical attributes for which there is high unmet need?

  • MOS and PFS are key drivers of physicians’ prescribing decisions and are the focus of drug development for new first-line advanced CaO therapies. What trade-offs across these and other clinical attributes are U.S. oncologists willing to make when considering the use of emerging CaO therapies? Based on trade-offs in price and performance across key attributes, how do physician preference and prescribing likelihood vary across different CaO target product profiles?

  • Based on its clinical profile, PLD + carboplatin 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 challenge PLD + carboplatin as the future gold standard in 2018 or 2023?

Scope:

Attributes included in conjoint analysis-based assessment of target product profiles for first-line advanced CaO:

- Median overall survival

- Median progression-free survival

- Delivery of maintenance therapy

- Rate of any grade bleeding

- Rate of grade 3/4 neutropenia

- Rate of any grade neuropathy

- Price per course of treatment

Attributes included in assessment of U.S. payers’ receptivity to new therapies for first-line advanced CaO:

- Improved effect on overall survival

- Improved effect on progression-free survival

- Lower incidence of grade 3/4 neutropenia

- Lower incidence of all grades neuropathy

Physicians surveyed: 61 U.S. and 30 European oncologists.

Payers surveyed: 20 U.S. MCO PDs.

Comprehensive List of Therapies Included in Our Research and Modeling:

Current Therapies

- Paclitaxel (Bristol-Myers Squibb’s Taxol, generics) + carboplatin (Bristol-Myers Squibb’s Paraplatin, generics)

- Paclitaxel (Bristol-Myers Squibb’s Taxol, generics) + cisplatin (Bristol-Myers Squibb’s Platinex, generics)

- Pegylated liposomal doxorubicin (Janssen Biotech’s Doxil/Caelyx) + carboplatin (Bristol-Myers Squibb’s Paraplatin, generics)

- Bevacizumab (Roche/Genentech/Chugai’s Avastin) + paclitaxel (Bristol-Myers Squibb’s Taxol, generics) + carboplatin (Bristol-Myers Squibb’s Paraplatin, generics) + bevacizumab maintenance

- Docetaxel (Sanofi’s Taxotere, generics) + carboplatin (Bristol-Myers Squibb’s Paraplatin, generics)

Emerging Therapies

- DCVAC/OvCa (Sotio) + paclitaxel (Bristol-Myers Squibb’s Taxol, generics) + carboplatin (Bristol-Myers Squibb’s Paraplatin, generics) + DCVAC/OvCa maintenance

- Chemotherapy + olaparib (AstraZeneca) maintenance

- Trebananib (Amgen/Takeda) + paclitaxel (Bristol-Myers Squibb’s Taxol, generics) + carboplatin (Bristol-Myers Squibb’s Paraplatin, generics) + trebananib maintenance

- Nintedanib (Boehringer Ingelheim’s Vargatef) + paclitaxel (Bristol-Myers Squibb’s Taxol, generics) + carboplatin (Bristol-Myers Squibb’s Paraplatin, generics) + nintedanib maintenance


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