In This Increasingly Crowded Setting, What Key Attributes Will Differentiate Emerging Therapies According to Oncologists and Payers?

Treatment decisions for non-small-cell lung cancer (NSCLC) patients are increasingly based on personalized tumor-specific characteristics. The first-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs), erlotinib (Genentech/ Roche/ Chugai /Astellas’s Tarceva) and gefitinib (AstraZeneca’s Iressa), have revolutionized the first-line treatment of EGFR-mutation-positive NSCLC, and crizotinib (Pfizer’s Xalkori) has made significant strides in treating anaplastic lymphoma kinase (ALK)-translocation-positive NSCLC. The outcome for previously treated EGFR-mutation-positive NSCLC patients is set to improve further based on the expected entry of third-generation EGFR inhibitors. The recent entry of ceritinib (Novartis’s Zykadia) and alectinib (Genentech/Roche/Chugai’s Alecensa) for previously treated ALK-translocation-positive NSCLC will significantly improve outcomes for these patients. Going forward, the market is expected to become increasingly competitive following the approval of the targeted second-generation and third-generation EGFR and ALK TKIs for previously treated, EGFR-mutation-positive/ALK-translocation-positive NSCLC. Significant clinical and commercial opportunity remains for therapies that can provide greater survival benefits with a better safety profile than current standards of care.

Questions Answered in This Report:

  • Overall survival and progression-free survival are key goals in the treatment of previously treated, EGFR-mutation-positive/ALK-translocation-positive NSCLC. 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 previously treated, EGFR-mutation-positive/ALK-translocation-positive NSCLC?

  • Increased overall survival, delayed disease progression, and improved tumor response are key areas of unmet need for previously treated, EGFR-mutation-positive/ALK-translocation-positive NSCLC according to the insights of surveyed U.S. and European oncologists. Which therapies in development for previously treated, EGFR-mutation-positive/ALK-translocation-positive NSCLC 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?

  • Median overall survival and price per 21-day cycle are key drivers of physicians’ prescribing decisions and/or are the focus of drug development for new previously treated, EGFR-mutation-positive/ALK-translocation-positive NSCLC 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 previously treated, EGFR-mutation-positive/ALK-translocation-positive NSCLC? 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 previously treated, EGFR-mutation-positive/ALK-translocation-positive NSCLC?

  • By 2018, AZD-9291 will emerge as the gold-standard therapy for previously treated, EGFR-mutation-positive NSCLC and alectinib will emerge as the gold standard for previously treated, ALK-translocation-positive NSCLC in our Drug Comparator Model because of their superior clinical profile over the key current therapies we evaluated in their respective populations. On what clinical attributes are AZD-9291 and alectinib most differentiated from their competitors? Which current therapies are at greatest risk of being replaced by AZD-9291 and alectinib?

Scope:

Attributes included in conjoint analysis-based assessment of target product profiles for previously treated, EGFR-mutation-positive/ALK-translocation-positive NSCLC:

- Median overall survival (MOS) (months).

- Median progression-free survival (PFS) (months).

- Overall response rate (% of patients).

- Rate of all grades skin rash (%of patients).

- Incidence of all grades diarrhea (% of patients).

- Hyperglycemia of all grades (% of patients).

- Price per 21-day cycle.

Attributes included in assessment of U.S. payers’ receptivity to new therapies for previously treated, EGFR-mutation-positive/ALK-translocation-positive NSCLC:

- Effect on median overall survival (MOS).

- Effect on progression-free survival (PFS).

- Incidence of grade 3/4 neutropenia.

- Incidence of neuropathy/neurosensory (all grades).

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:

Current Therapies

- Pemetrexed (Eli Lilly’s Alimta)

- Docetaxel (Sanofi’s Taxotere, generics)

- Gemcitabine (Eli Lilly’s Gemzar, generics) + cisplatin (generics)

- Pemetrexed (Eli Lilly’s Alimta) + cisplatin

- Paclitaxel (Bristol-Myers Squibb’s Taxol, generics) + carboplatin (generics) + bevacizumab (Genentech/Roche/Chugai’s Avastin)

Emerging Therapies

- AZD-9291 (AstraZeneca)

- Rociletinib (Clovis Oncology/Celgene’s CO-1686)

- Alectinib (Genentech/Roche/Chugai’s Alecensa)

- Ceritinib (Novartis’s Zykadia)

- Brigatinib (Ariad Pharmaceuticals’ AP-26113)


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