Market Conditions that Impact New Oncology Product Uptake

By Jackie Ilacqua, Global Head of Oncology, Ipsos Healthcare

Although there have been more drug approvals in the oncology space than in any other—as many as 49 drugs have been approved by the U.S. Food and Drug Administration (FDA) for the treatment of cancer over the past five years1—time to reach peak share has shortened due to new products launching in more targeted subsets of patients over the last decade. Looking back on the last five years of new oncology product launches, it becomes clear that the impact of new products is dictated not only by clinical trial data but also by the tumor market characteristics.

Since 2009, the greatest influx of new product launches across tumor types have been seen in melanoma, breast cancer, chronic myelogenous leukemia (CML), chronic lymphocytic leukemia (CLL), and non-small cell lung cancer (NSCLC). Melanoma has witnessed the largest number of new entrants, with five products approved (Mekinist, Tafinlar, Yervoy, Zelboraf, and Sylatron); followed by breast cancer with four (Kadcyla, Perjeta, Afinitor, and Halaven), and three drugs each in CML (Synribo, Iclusig, and Bosulif), CLL (Zydelig, Imbruvica, and Gazyva), and NSCLC (Xalkori, Zykadia, and Gilotrif).

The Change in Speed of Product Uptake Over Time

Overall, the speed of uptake of cancer drugs has increased dramatically in the past ten years, with products reaching peak share much earlier now than in the past. Biologic agents also have a faster speed of uptake compared to cytotoxic drugs, and drugs approved for solid tumors will have a faster uptake than drugs approved for hematologic malignancies (Source: Ipsos Oncology Analog Uptake Tool).  This is assuming that the cancer drug even makes it to market, as half of all phase III clinical trial failures in 2013 were cancer drugs.2

The impact of a product on the market is heavily dictated by market conditions: uptake curves at launch differ according to order of entry, unmet need in the area the drug is approved for, presence of a companion diagnostic, regimen type, testing results, specificity of the approval, and more. To illustrate this point, let’s consider some drug launches in more detail across 3 tumor types.

Non–small Cell Lung Cancer

Looking at the launch pattern of Xalkori (crizotinib) for NSCLC (Figure 1), Ipsos Healthcare data show that the product reached its peak share 29 months after its U.S. launch in August 2011, but also, that it was very close to its peak directly after launch. This is indicative of the need in the market and the anticipation for this drug’s approval, most likely reinforced by the fact that its indication is limited to a small and very specific subset of patients—those that test positive for the ALK fusion gene. After its initial positive reaction, share of the drug dropped about a year after launch before returning to hit its peak share of 77%.

Market Conditions that Impact New Oncology Product Uptake (continued)

Breast Cancer

Meanwhile, when we looked at the launches of new drugs in breast cancer we saw how the regimen type and the order of approval had an impact on the market. Perjeta (pertuzumab) and Kadcyla (ado-trastuzumab emtansine) launched within a year of one another, and both had a significant impact on the breast cancer market. Perjeta launched as a combination product with Herceptin (trastuzumab) and, as such, had a small positive impact on overall Herceptin use (Figure 2). Kadcyla, on the other hand, was approved as a subsequent therapy to Herceptin. However, we saw that Kadcyla had a negative impact on Herceptin share, stealing share largely amongst latter-line patients (Figure 2).

Melanoma

Order of entry had a real impact on share for new products in melanoma. The first BRAF inhibitor, Zelboraf (vemurafenib), achieved a share of over 60% in the first quarter after FDA approval; subsequent products such as the dabrafenib/trametinib combination showed a significantly slower uptake to peak share (Figure 3a) despite being viewed as equally effective and covering a greater range of BRAF mutations. Zelboraf had addressed a significant unmet need in this hard to treat population first, but as the unmet need fell, so did the impact of subsequent therapies.
 
 
As evidenced in melanoma, new product launches not only have an impact on the treatments within that market, but also on physician behavior, such as testing rates. Before the approval of Zelboraf, physicians had very little reason to test patients for BRAF mutations. However, when Zelboraf was approved, testing rates increased dramatically (Figure 3b.)
 

Market Conditions that Impact New Oncology Product Uptake (continued)

How will Physicians Perceive the Future on Product Launches?

To better understand the perceptions of US oncologists on how product launches will impact cancer treatment in the future, Ipsos Healthcare fielded a small survey (n=86) to the Ipsos Healthcare US Oncology Monitor Panel (a 5-minute perceptual online survey), seeking to gauge views.

Tumors Likely to See Advances in Treatment over the Next Few Years

When asked in which tumor type the physicians foresee the greatest advances, over half of respondents (53%) stated that lung cancer is the main tumor likely to see advances in treatment over the next few years.  Thirty-eight percent were excited about the advances in breast cancer treatment, while 34% indicated lymphoma as a tumor with treatment progress in coming years. 

The Most Anticipated Drug Classes

When asked about the most anticipated drug classes, immune checkpoint inhibitors and PI3K inhibitors (each with over 85 active trials), and BTK inhibitors (with over 20 active trials) were mentioned most often.

The New Drugs with Greatest Potential

According to the survey, the following 3 drugs were said to have the greatest future potential.

Nivolumab (BMS): Nivolumab works by blocking a protein called programmed cell death 1 (PD-1). Drugs which inhibit PD-1 may be able to treat a variety of cancers. Bristol-Myers Squibb is currently enrolling participants in clinical trials for lung cancer, melanoma, renal cell carcinoma, and other advanced or metastatic solid tumors. Nivolumab was launched in Japan in July 2014 making it the first PD-1 to market in that country.


Idelalisib (Gilead): Idelalisib is a targeted oral inhibitor of phosphoinositide 3-kinase (PI3K) delta, a protein that is critical for the activation, proliferation and survival of B lymphocytes. It was in trials for iNHL and CLL at the time the survey was fielded, and has since been approved for CLL.

Ibrutinib (Janssen/Pharmacyclics): Ibrutinib is a first in class oral tyrosine kinase inhibitor and is used to treat CLL and a type of NHL known as mantle cell lymphoma. Since the survey was fielded, its approval has been expanded to CLL patients with 17p deletions. It is also being studied for use against other types of leukemia, lymphoma, and other cancers.

New Oncology Research & Product Development

Lastly, when cancer-treating physicians were asked which pharmaceutical companies they perceive to be leaders in cancer, Genentech was mentioned by half of the physicians, followed by Novartis with a little over a third of responses, and Pfizer and Amgen each with around 25%.

In Conclusion

Despite high phase II and phase III trial failure rates, the oncology development landscape is still crowded, with nearly 50 FDA approvals in 5 years. Many of these new compounds have been approved on the basis of showing significant efficacy in niche indications; companion diagnostics are a big part of the approval process and have helped propel shares provided testing rates don’t lag behind. Several recent examples of new entrants targeting the same specific subset of patients have launched in niche indications, but the being first to market is often crucial for maximizing peak share.

Although many new players have entered the oncology space with recently launched products and/or promising pipeline products, and although some of these products have generated a lot of excitement among our panel doctors, those same doctors still largely regard the traditional players as being the leaders in oncology.

Clearly, success in the oncology space is highly sought after for pharmaceutical companies, and it is still possible to see very quick uptake—albeit often in small patient segments—despite the ever-increasing competition. We have discussed several examples of products that have successfully negotiated the challenges facing any new entrant in this space and one thing is clear: companies must continue to be innovative and to re-think launch strategies, especially if they seek to be recognized by physicians as one of the top oncology companies in the industry.

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Resources

  1. U.S. Food and Drug Administration. Hematology/Oncology (Cancer) Approvals & Safety Notifications. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm279174.htm. Accessed November 8, 2014.
     
  2. Genetic Engineering & Biotechnology News. Top 10 Clinical Trial Failures of 2013. http://www.genengnews.com/insight-and-intelligence/top-10-clinical-trial-failures-of-2013/77900029/. Accessed November 8, 2014.

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About the Contributor

Jackie Ilacqua is Global Head of Syndicated Services and President of Global Oncology of Ipsos Healthcare, leading the company’s syndicated and custom oncology business around the globe. She is also a member of the Ipsos Healthcare Board.  She can be reached at 201-574-8079 or jackie.ilacqua@ipsos.com.

Ipsos Healthcare, operating in 40 countries around the world, is a global specialized practice focusing on research in the pharmaceutical, bio-tech and medical device markets.  Ipsos Healthcare’s Syndicated Services include the market-leading Global Oncology Monitor and Global Therapy Monitors, which, together, comprise the industry’s largest portfolio of syndicated patient chart audit data. The Syndicated Services portfolio also includes oncology molecular diagnostics, oncology social listening, disease-specific ethnography studies and a suite of commercial strategy offerings.

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