By Ed Kissel, VP, Quantitative Analysis December 2008
Source: Med Ad News
Pharmaceutical researchers of non-small cell lung cancer drugs can more closely hit the mark by examining the real-world events that shape the use of successful drugs. Representing a $2.2 billion slice of the overall annual U.S. chemotherapy market, lung cancer is one of the most common tumors alongside breast and colorectal cancers.
The landscape for chemotherapy drugs for non-small cell lung cancer has undergone dramatic changes in the past five years as new drugs have become available and existing drugs have been approved for use in new settings. Analysis of key events, and the response to efforts by pharmaceutical marketers, in this segment of cancer care presents a glimpse into what factors influence a drug’s success or failure.
Avastin, marketed by Genentech Inc. (gene.com) and Roche (roche.com); Alimta, marketed by Eli Lilly and Co. (lilly.com); and Tarceva, marketed by Genentech, collectively represent the most widely used chemotherapy drugs for advanced non-small cell lung cancer, yet each has taken a very different path to achieve the market share they command today.
Physicians had familiarity with both Avastin and Alimta, which were approved in other indications before use in non-small cell lung cancer. Though Tarceva’s initial approval was in non-small cell lung cancer, physicians were already familiar with a very similar, albeit less effective, product named Iressa, marketed by AstraZeneca (astrazeneca.com). Where these three drugs differed most was in the pivotal pre-approval studies, where each drug was examined in very different non-small cell lung cancer populations. This, along with the associated marketing messages accompanying the results of subsequent clinical trials, led to changes in use of these drugs throughout the past few years.
In medical oncology, the effective communication of clinical data is the single biggest driver of a product’s inflection point. This is even more pronounced in secondary market entries, where doctors already have a baseline familiarity with a drug. Avastin is a perfect example. Release of initial Phase III trial results in front-line combination with the standard of care in the spring of 2005 and 18 months before the drug’s official FDA approval immediately sparked 40% of the drug’s peak performance in non-small cell lung cancer, its second tumor market. Only one-third of Avastin’s peak performance is directly attributed to the official FDA approval in October 2006.
Unlike more traditional retail pharmaceutical markets, the success of oncology drugs relies heavily on well-planned and researched clinical trials. The extra up-front investment is almost always rewarded in maximizing market opportunity.
Unlike Avastin, Alimta saw its peak market performance three years after its 2004 FDA approval, driven by a shift in messaging.
Alimta initially targeted a highly specific market – relapsed non-small cell lung cancer patients – with a message of “safety with comparable efficacy.” In that setting, the drug quickly gained acceptance. In the long term, however, its messaging left the drug vulnerable to competitive threats and fostered its perception as a niche drug. Uncertain market performance that ensued negatively affected the drug’s use for two full years.
In June 2006, clinical data was released about Alimta that built on the drug’s efficacy messages. This was the beginning of a strategic shift to educate physicians on Alimta’s statistically significant improvements in efficacy, which ultimately enabled the drug to sustain growth and defend against competitive pressure.
Alimta’s patient population grew 25% while efficacy messages took center stage. The new messaging successfully enabled Alimta to penetrate new markets and migrate usage into earlier lines of therapy – growing its first line of therapy patient population by 60%.
Tarceva, a widely used oral drug, was approved based on an improvement in survival compared with placebo for patients whose disease continued to progress while on other products. Physicians perceive this drug as painted by the pivotal clinical trial, as the last line of therapy for non-small cell lung cancer.
This perception as the last treatment option has hampered the drug’s market potential. To grow from its current stagnant position, Tarceva’s team must build on messages of efficacy, or define new custom markets.
For example, combination use with established intravenous anticancer drugs might enable Tarceva to grow from its stagnant position. An interesting custom market may be first-line maintenance in non-small cell lung cancer, where the convenience of an oral drug coupled with an efficacy message could drive renewed success.
Success in the oncology market is driven by hitting the target in all three core categories: clearly communicating clinically significant data to the drug prescriber, accurately defining the custom market, and emphasizing the right set of messages to avoid limiting a drug’s potential growth.
Messaging for efficacy continues to be the best way to win physicians’ endorsement. Messages around safety can gain strong market share especially in later, or “last,” lines of therapy, but will ultimately hinder penetrating the first line of therapy. When strong efficacy claims cannot be provided in the short term, marketers that expand the market or define new targeted, custom markets will help the product continue its growth.