Oncologists Are Eager for Therapies Extending Overall Survival

Ovarian cancer (CaO) ranks fifth in cancer deaths among women, accounting for more deaths than any other cancer of the female reproductive system in the United States (American Cancer Society, 2014). In 2012, more than 40,000 cases of advanced CaO were reported across the seven major pharmaceutical markets that we cover (United States, France, Germany, Italy, Spain, United Kingdom, and Japan). The nonmetastatic patients within this population are treated with curative intent, while the metastatic patients are treated with the goal of slowing disease progression and extending overall survival. Current regimens for first-line advanced CaO include combinations of taxanes (paclitaxel [Bristol-Myers Squibb’s Taxol, generics], docetaxel [Sanofi’s Taxotere, generics]), platinum agents (cisplatin [Bristol-Myers Squibb’s Platinex, generics], carboplatin [Bristol-Myers Squibb’s Paraplatin, generics]), pegylated liposomal doxorubicin (PLD; Janssen Biotech’s Doxil/Caelyx), and one targeted agent (bevacizumab [Roche/Genentech/Chugai’s Avastin]). The emerging therapies considered in the report are all targeted agents (i.e., pazopanib [GlaxoSmithKline’s Votrient], olaparib [AstraZeneca’s AZD-2281], trebananib [Amgen/Takeda’s AMG-386], and nintedanib [Boehringer Ingelheim’s Vargatef]), which are being evaluated in combination with current therapies, most commonly in combination with the paclitaxel + carboplatin regimen. 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:

  • Improved overall survival and improved time to disease progression are key goals in the treatment of first-line advanced CaO. 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 overall survival, delayed disease progression, a lower rate of neurotoxicity, and a lower rate of hematological toxicity are key areas of unmet need for improved time to disease progression and are key goals in the treatment of first-line advanced CaO according to the insights of surveyed U.S. and European oncologists. Which therapies in development for first-line advanced CaO 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. managed care organization pharmacy directors (MCO PDs) seek from new therapies on key clinical attributes for which surveyed physicians indicate there is high unmet need?

  • Despite the potential launch of several emerging therapies in the first-line advanced CaO market over our ten-year forecast period, PLD + carboplatin will remain the gold-standard therapy in our Drug Comparator Model. On what clinical attributes is PLD + carboplatin most differentiated from its competitors? What are the weaknesses of this therapy on which emerging therapies can capitalize? Which emerging therapies, if any, pose the greatest threat to PLD + carboplatin as well as the other key current therapies?

Scope:

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

- Median overall survival

- Median progression-free survival

- Overall response rate

- Rate of grade 3/4 neutropenia

- Rate of any grade neuropathy

- Rate of any grade diarrhea

- 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 grade 3/4 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 + cisplatin (Bristol-Myers Squibb’s Platinex, generics)

- Pegylated liposomal doxorubicin (Janssen Biotech’s Doxil/Caelyx) + carboplatin

- Bevacizumab (Roche/Genentech/Chugai’s Avastin) + paclitaxel + carboplatin + bevacizumab maintenance

- Docetaxel (Sanofi’s Taxotere, generics) + carboplatin

Emerging Therapies

- Chemotherapy + pazopanib (GlaxoSmithKline’s Votrient) maintenance

- Chemotherapy + olaparib (AstraZeneca’s AZD-2281) maintenance

- Trebananib (Amgen/Takeda’s AMG-386) + paclitaxel + carboplatin + trebananib maintenance

- Nintedanib (Boehringer Ingelheim’s Vargatef) + paclitaxel + carboplatin + nintedanib maintenance


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