Of the Several Exciting Agents in Late-Stage Development, Do Any Have the Potential to Dramatically Improve Survival?

Non-small-cell lung cancer (NSCLC) accounts for approximately 85% of all lung cancers; of these lung cancers, approximately 90% are EGFR wild-type/untested. Despite significant advances in the treatment of advanced/metastatic NSCLC in the first-line setting, treatment options for later-line settings have not changed over the past decade. Chemotherapies such as docetaxel (Sanofi’s Taxotere, generics) and pemetrexed (Eli Lilly’s Alimta) and the EGFR inhibitor erlotinib (Genentech/Roche/Chugai/Astellas’s Tarceva) remain the standards of care for EGFR wild-type/untested patients. No targeted agents are available in the second- and later-line settings; therefore, these patients remain difficult to treat. Thus, significant clinical and commercial opportunity remains for novel, highly efficacious, and tolerable therapies.

Questions Answered in This Report:

  • Improved median overall survival (MOS) and improved progression-free survival (PFS) are key goals in the treatment of second- and later-line EGFR wild-type/untested 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 wild-type/untested NSCLC?

  • Erlotinib is the 2012 major-market sales leader for previously treated EGFR wild-type/untested NSCLC. What weaknesses exist in its profile that would allow emerging therapies to gain traction in the market? Have emerging therapies demonstrated strengths on the attributes that surveyed oncologists indicate are the most important in their prescribing decisions? Which emerging therapies will offer the clinical improvements over currently available therapies that surveyed MCO PDs seek from new therapies?

  • MOS and price per cycle are key drivers of physicians’ prescribing decisions. What trade-offs across these and other clinical attributes are U.S. oncologists willing to make when considering the use of current and emerging therapies for previously treated EGFR wild-type/untested 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 wild-type/untested NSCLC?

  • By 2017, pembrolizumab will emerge as the gold-standard therapy in our Drug Comparator Model because of its superior clinical profile over the key current therapies we evaluated. On what clinical attributes is pembrolizumab most differentiated from its competitors? Which current therapies are at greatest risk of being replaced by pembrolizumab?

Scope:

Attributes included in conjoint analysis based assessment of target product profiles for previously treated EGFR wild-type/untested NSCLC:

- Median overall survival (months).

- Median progression-free survival (months).

- Objective response rate (% of patients).

- Availability of predictive biomarker.

- Incidence of grade 3/4 neutropenia (% of patients).

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

Attributes included in assessment of U.S. payers’ receptivity to new therapies for previously treated EGFR wild-type/untested NSCLC:

- Effect on MOS.

- Effect on PFS.

- Incidence of grade 3/4 neutropenia.

- Incidence of all grades rash.

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

- Erlotinib (Genentech/Roche/Chugai/Astellas’s Tarceva)

- Docetaxel (Sanofi’s Taxotere, generics)

- Pemetrexed (Eli Lilly’s Alimta)

Emerging Therapies

- Nivolumab (Bristol-Myers Squibb/Ono Pharmaceutical)

- Pembrolizumab (Merck & Co.)

- Dacomitinib (Pfizer)

- Onartuzumab (Genentech/Roche/Chugai’s MetMAb) + erlotinib

- Selumetinib (AstraZeneca) + docetaxel


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