By Brianza Nyborg (Contributing Author)
A new market research report published earlier this year by Reportlinker.com discusses the increased importance of targeted therapies in the treatment of patients with cancer. The report describes how changes the availability of thearpies is expected to influence the market for a number of drugs. The report offers a clear overview of a very dynamic oncology sector and reviewes the available targeted therapies which are shaping the current landscape and the research, and are expected to change future treatment paradigms. [1]
The introduction of targeted therapies revolutionized the treatment of breast cancer. It widened clinical options and resulted improved survival rates and lower side effects for patients treated with these novel drugs. Now the phramaceutical sector is set for further positive change and expansion as next generation products for HER2-positive disease come to market and CDK4/6 and P13K inhibitors hold the prospect of new treatments for hormone receptor-positive and HER2-negative breast cancer patients ? an area of huge unmet clinical need. But which companies and products will change the commercial and clinical landscape over the next 5 years?
Ado-trastuzumab emtansine is a tremendous step forward. It’s as big an advance as trastuzumab was when that was first developed. It’s clearly very effective and it’s also very well tolerated, so it’s a win-win really for the patients.
Changes in the treatment of breast cancer
The current market for breast cancer consists of five monoclonal Antibodies (mAbs), three of which are targeted at the Human Epidermal growth factor Receptor 2 (HER-2) protein. Four are aimed at improving overall survival in the metastatic setting, and two of these have
also received further approvals in the early setting in order to improve long-term remission rates.
Market analysts expect that ado-trastuzumab emtansine (T-DM1,Kadcyla?; Genentech) and pertuzumab (Perjeta?; Genentech) are set to transform the treatment of HER2-positive breast cancer.
Both ado-trastuzumab emtansine and pertuzumab are viewed as significant steps forward in the treatment of breast cancer. When added to trastuzumab (Herceptin?; Genentech) pertuzumab is the first drug to improve survival in the first-line setting since the availability of trastuzumab in 1998. Ado-trastuzumab emtansine is the first antibody-drug conjugate for the treatment of breast cancer and improves overall survival by almost six months in the second-line setting. The drug has been well received.
“Ado-trastuzumab emtansine is a tremendous step forward. It’s as big an advance as trastuzumab was when that was first developed. It’s clearly very effective and it’s also very well tolerated, so it’s a win-win really for the patients. I’ve been amazed at both the responses and the low side-effect profile of treatment. So, I can see it probably sweeping the board in time,” noted one European Key Opinion Leader quoted in the report.
To Genentech’s commercial benefit, both drugs are set to expand their indications and will likely dominate the market in both the early stages and first lines of treatment for metastatic disease.
“There’s more and more evidence showing that using combination HER2 blockade is the right thing to do. So, at the moment, I think it [trastuzumab] will remain the backbone of the combination approach. If the patient relapsed on ado-trastuzumab emtansine then you might go on to trastuzumab plus pertuzamab or trastuzumab plus pertuzamab plus another drug.”
A biosimilar trastuzumab?
Although the availability of biosimilar versions of trastuzumab will likely expand in the near future, the prospects of these biosimilar versions are not expected to be very bright.
“There are issues that have not yet been well-defined for biosimilars. My decision to use a biosimilar will depend on the basis of approval. I need more transparency to be confident. Has it been used in the metastatic setting? Can it be used in the adjuvant setting? Will there be testing for cardiotoxicity? The answers to these questions should be clear. I don’t think there will be much use of biosimilar trastuzumab because the criteria used by the European Medicines Agency (EMA) are very [different], so this drug [biosimilar trastuzumab] is basically less tested. We don’t trust the development.”
Ado-trastuzumab emtansine and pertuzumab look set to overtake trastuzumab in the early stages and first-line treatment of metastatic HER2-positive breast cancer, thereby limiting the role of biosimilar trastuzumab. Furthermore, Genentech’s subcutaneous trastuzumab offers more convenient administration than intravenous biosimilar versions. Clinical scepticism and defensive pricing will further limit the prospects for biosimilars in established markets.
Hormone receptor positive
Analysts expect that new clinical approaches will transform the treatment of hormone receptor-positive and HER2-negative breast cancer.While everolimus Afinitor?, Novartis) improves progression-free survival in patients with hormone receptor-positive, HER2-negative metastatic breast cancer, it is also highly toxic. Hence, interest is now focussed on promising late-stage pipeline candidates.
The pipeline drugs palbociclib (formally known as PD-0332991; Pfizer), which made a grand debut at the 2012 CTRC-AACR San Antonio Breast Cancer Symposium (SABCS) when Richard S. Finn, MD, from the Jonsson Comprehensive Cancer Center at the University of California, Los Angeles, presented interim results of the PALOMA-1 trial, and LEE011, a small-molecule inhibitor of cyclin-dependent kinases (CDK) 4/6 being developed by Novartis Oncology, are locked in a race to become the first-to-market CDK4/6 inhibitor.
“Right now I am most excited and encouraged with the CDK 4/6 inhibitor palbociclib. It is an oral therapy; it is well tolerated; and it shows improvements in efficacy that are double to triple of what we have seen with hormonal therapy alone. So far, I am very excited about it and I think it is going to move quickly.”
Both drugs are expected to improve survival when combined with an aromatase inhibitor in the first-line treatment of this patient segment and at a lower cost in terms of toxicity. The treatment of hormone receptor-positive, HER2-negative breast cancer will be transformed by the availability of these and PI3K inhibitors such as buparlisib (formerly known as BKM120; Pfizer).
For more information:
[1] Breast Cancer: New targeted therapies transform treatment – KOL Insight
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