The UK’s cost-effectiveness watchdog National Institute of Health and Clinical Excellence (NICE) has delivered another blow to the developers of targeted cancer therapies by recommending against the use of four new kidney cancer drugs in the UK. This recommendation suggests that NICE is likely to look unfavorably on a number of other targeted therapies in development, severely limiting future growth of the targeted cancer therapies market in the UK.
In its preliminary guidance report on a number of new targeted cancer therapies, the UK’s NICE has stated that Avastin (bevacizumab; Genentech/Roche/Chugai), Nexavar (sorafenib; Bayer/Onyx), Sutent (sunitinib; Pfizer) and Torisel (temsirolimus; Wyeth) are not cost-effective for the treatment of advanced or metastatic renal cell carcinoma (RCC). If finalised, this guidance would mean that RCC patients in the UK will not be able to receive these therapies on the National Health Service (NHS).
The draft guidance is the latest in a series of negative recommendations from NICE to affect premium-price targeted cancer drugs, including Avastin for colorectal, lung and breast cancer, and Tykerb (lapatinib; GlaxoSmithKline) for breast cancer. NICE’s recommendation for RCC suggests that, without offering large improvements in overall survival, expensive targeted therapies are unlikely to receive a positive recommendation, regardless of the level of unmet need in a particular indication.
In order to attempt to persuade NICE to reverse its decision, the developers of these drugs may consider offering substantially discounted prices in the UK. This would follow Roche’s decision to reduce the price of its non-small cell lung cancer drug Tarceva (erlotinib) in the UK in July 2008, in order to satisfy NICE’s cost-effectiveness criteria.
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September 22nd, 2008 at 11:56 am
Data from a Phase II study of GlaxoSmithKline’s Tykerb in head and neck cancer point to the potential for it to achieve expansion beyond the breast cancer market. Phase III development of the drug in the adjuvant head and neck cancer setting could prove to be more successful than an initial launch in the advanced/metastatic setting, where competition from Erbitux is likely to restrict sales.
In the randomized Phase II study, 107 patients with previously untreated locally advanced squamous cell carcinoma of the head and neck (SCCHN) received either Tykerb (lapatinib; GlaxoSmithKline) or a placebo before treatment with standard platinum-based chemotherapy and radiotherapy. The results showed a statistically significant reduction in tumor cell proliferation in the Tykerb arm of the study (-8% vs -2.7% in the placebo arm, p=0.039). In 88 patients who underwent radiological analysis, the overall response rate was higher in the Tykerb arm than in the placebo arm (86% vs 63%) and the complete response rate was also higher in the Tykerb arm (28% vs 7%). However, GlaxoSmithKline did not state whether the difference in response rates reached statistical significance.
Tykerb is an orally available small molecule that inhibits two key receptors associated with tumor growth: EGFR (ErbB1) and HER2 (ErbB2). A number of tumors show overexpression of at least one of these receptors, including SCCHN, where it is associated with a poor prognosis. Tykerb is approved in the US and EU in combination with Xeloda (capecitabine; Roche) for the treatment of advanced or metastatic HER2-positive breast cancer which has progressed following treatment with Herceptin (trastuzumab; Genentech/Roche).
Erbitux (cetuximab; ImClone/Bristol-Myers Squibb/Merck Serono), a monoclonal antibody which also targets EGFR, is the only targeted therapy available for head and neck cancer, and is approved in the US and EU for advanced/metastatic SCCHN. Erbitux’s first-to-market advantage and its established status as standard-of-care could restrict the uptake of other targeted therapies commercialized for advanced/metastatic SCCHN.
It appears likely that GlaxoSmithKline does not initially intend for Tykerb to compete directly with Erbitux in locally advanced/metastatic SCCHN. Instead, it has launched a Phase III study evaluating Tykerb plus concurrent chemotherapy/radiotherapy in the adjuvant setting in patients who have undergone surgical resection (the MAINTYNANCE trial). If Tykerb is successful in this Phase III trial, it could achieve considerable market penetration in this area, given the lack of competition from other approved targeted therapies. However, while the reported Phase II results for Tykerb in locally advanced SCCHN suggest promising activity in this tumor type, it is far from certain whether this will translate into meaningful efficacy in the adjuvant setting.