Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
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Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
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SEARCH JOBSThe buzz surrounding obesity pharmacotherapies has been fueled by the impressive weight-loss delivered by novel agents. However, such a singular focus on headline efficacy figures is overly simplistic and ignores other important criteria a successful obesity therapy must meet.
In particular, a clean tolerability profile is critical for the long-term treatment of a chronic condition. The strong reaction by financial markets to recent obesity trial readouts suggests that discerning investors look beyond weight loss and are increasingly sensitive to tolerability data. A competitive, patient-relevant product profile must carefully balance efficacy and gastrointestinal, treatment-emergent adverse events (GI-TEAEs), such as nausea, vomiting or diarrhea. These are the most common side effects observed with many novel obesity therapies, which may even lead to patients discontinuing treatment.
As we elaborated in an earlier IQVIA blog1, the future obesity market will look very different from today’s – more segmented, defined by nuanced patient needs and where competitors must seek clear differentiation. Therefore, optimizing an obesity asset’s profile along the dimensions of efficacy and tolerability forms the foundation for building a differentiated value proposition.
In this blog, we will review the emerging landscape of obesity pharmacotherapies through the lens of GI-tolerability and explore the multi-dimensional nature of differentiation for these medicines.
Rates of GI-TEAEs vary considerably among obesity therapies, making GI-tolerability an important differentiator alongside efficacy, as illustrated in Figure 1. It shows the distinct GI-tolerability profiles of selected anti-obesity medications, including injectable and oral therapies. GI-tolerability is measured as event rates observed in clinical trials, at the highest dose, along five dimensions: nausea, vomiting, constipation, diarrhea and treatment discontinuation due to adverse events. Of note, these are cross-trial comparisons, with their inherent limitations, which also include data of different maturity spanning phase 1 to phase 3 trials.
For this sample of anti-obesity medications we find a wide range of GI event rates, for example from 31% to 83% for nausea, 12% to 56% for vomiting and 0% to 20% for AE-related treatment discontinuation. Such differences in tolerability matter to patients, especially in the context of long-term maintenance therapy of obesity.
There are some important considerations for interpreting and comparing GI-tolerability data for obesity therapies, which are derived from common patterns observed across relevant clinical trials (see Figure 2):
These observations made across relevant clinical trials hold important lessons for innovators and should inform strategic trial designs that help them optimize the different levers of tolerability for their obesity assets.
A meaningful, patient-relevant perspective of the emerging landscape of anti-obesity medications must consider efficacy in the context of tolerability to understand competitive profiles and whether they favorably trade off these two dimensions.
To that end, we segmented a sample of 15 prominent obesity assets into tolerability quartiles based on total nausea rates reported in relevant clinical trials at the highest dose. Looking at quartiles strikes a pragmatic balance: It allows differentiation of assets on the basis of tolerability while avoiding undue granularity, which recognizes inherent limitations such as a simplified representation of the multi-faceted nature of tolerability and its drivers, or differences in data maturity between assets.
Overlaying efficacy for each asset, delivered at discrete time points, at the highest dose and measured as placebo-adjusted weight loss, provides a differentiated perspective of the emerging obesity therapy landscape (see Figure 3). The caveat of cross-trial comparisons, with their inherent limitations, applies.
This lens introduces a ‘competitive frontier’ for each tolerability quartile, at different time points, which represents the respective, most favorable trade-offs between efficacy and tolerability achieved to date.
In this framework, the current competitive frontier defined by oral obesity therapies consistently trails that for injectables, across time points and tolerability quartiles. Furthermore, the distinctive, staircase-like shape of the competitive frontier, which holds across all time points, implies that greater, peer-leading efficacy comes at the expense of GI-tolerability for our sample of obesity assets.
This notion of a competitive frontier sets a meaningful benchmark that reflects multiple, patient-relevant dimensions of benefit and provides useful context for interpreting competitive profiles of different assets, for example:
As we discussed earlier, optimizing an obesity asset’s profile along the dimensions of efficacy and tolerability forms the foundation for building a differentiated value proposition, which is a key prerequisite for success in the future obesity market.
This effort must start in early development, when innovators define a compelling target product profile (TPP) which subsequently is translated into the clinical development programme. Strategic trial designs are critical to optimize an obesity asset’s competitive profile, including a most favorable efficacy-tolerability trade-off, while demonstrating value against payer- and patient-relevant endpoints.
Beyond clinical trials, real-world evidence (RWE) will play a key role, e.g., comparative, real-world tolerability studies, to demonstrate differentiation between obesity therapies in routine medical practice. A clean tolerability profile is a critical differentiator, as patients’ real-world tolerance of GI-TEAEs can be expected to be low, especially for ongoing maintenance treatment of obesity as a chronic condition, which impacts levels of adherence and persistence, and in turn patient outcomes.
Finally, innovators will need to become adept at communicating the multi-dimensional value of their obesity assets, beyond weight loss, to different stakeholders, including patients, payers and HCPs. This will require a combination of promotional and non-promotional engagement involving close collaboration between sales, marketing, market access and medical functions.
Innovators should be left in no doubt: The race to tackle tolerability is on!
References
Check out the knowledge hub for more insights on obesity.
Discover new approaches to cardiovascular clinical trials to bring game-changing therapies to patients faster.
