SMC says ‘yes’ to new blood cancer drug

From today, patients in Scotland with chronic lymphocytic leukaemia (CLL) could benefit from Gazyvaro, which has been given the green light by the Scottish Medicines Consortium (SMC) for routine use on the NHS.¹ Gazyvaro has been recommended for use in combination with chlorambucil chemotherapy for the treatment of previously-untreated adult patients with CLL and co-existing medical conditions who are unsuitable for full-dose fludarabine-based therapy.^2,3

Yvonne Dickson, Head of Scotland at the charity Leukaemia & Lymphoma Research, said: “The approval of Gazyvaro by the SMC is very positive news for Scottish patients with chronic lymphocytic leukaemia. This type of leukaemia remains largely incurable, so it’s vital that when advances in treatment are made that can prolong survival times, patients can benefit from them.”

Data from the main study of the drug (CLL11), which was trialed in Scotland, showed that Gazyvaro, combined with chemotherapy, reduced the risk of death by 59% (HR 0.41 95% CI 0.23–0.74, p=0.002)⁴ and meant that patients remained in remission more than 15 months longer than those receiving chemotherapy alone (median progression free survival (PFS) 26.7 months versus 11.1 months, HR 0.18, CI 0.13-0.24, p<0.001).⁴ In addition, more than one in five (22.3%) patients receiving Gazyvaro was in complete remission after treatment.⁴ In contrast, no patients achieved complete remission when receiving the current standard, chemotherapy alone.⁴

Jayson Dallas, General Manager, Roche UK, said: “We are very pleased that patients in Scotland will be able to benefit from access to Gazyvaro, which has shown, in trials, to provide a significant survival advantage over the standard therapy. What’s important is that Government, health assessment bodies and the pharmaceutical industry across the UK work positively together to ensure that the value and benefits of innovative new medicines continue to be recognised so that access to these important cancer therapies is equitable and safeguarded for all, now and in the future.”

Gazyvaro is the first ‘type II’ anti-CD20 monoclonal antibody licensed for the treatment of CLL^5,6,7 and is designed to attack blood cancers more aggressively than ‘type I’ treatments such as MabThera^® (rituximab).⁵ Gazyvaro has the ability to kill cancer cells directly by seeking them out and attaching to them.^5,7 In addition, Gazyvaro is able to alert the body’s immune system to ‘enemy’ cancer cells, allowing immune cells to attack and destroy the cells more effectively (antibody-dependent cellular cytotoxicity) than other treatments such as MabThera.⁵

Gazyvaro has been shown to have a manageable tolerability profile when used in combination with chemotherapy.  The most common adverse events associated with Gazyvaro in the CLL11 study were infusion-related reactions (IRRs).⁴ 21% of patients experienced a severe IRR, however no severe IRRs were observed after the first full dose of treatment.⁴ Other severe adverse events reported were neutropenia (35%), low platelet count (thrombocytopenia) (11%), infections (11%), anaemia (5%), leukopenia (5%).⁴

References

1.  http://www.macmillan.org.uk/Cancerinformation
   /Cancertypes/Leukaemiachroniclymphocytic/AboutCLL/Wha tisCLL.aspx Last accessed December 2014.
2. Scottish Medicines Consortium (SMC). Detailed Advice: obinutuzumab (Gazyvaro). December 2014.
3. Gazyvaro (obinutuzumab). Summary of Product Characteristics. Available via www.medicines.org Last accessed: December 2014
4. Goede V et al. Obinutuzumab plus Chlorambucil in Patients with CLL and Coexisting Conditions. New Eng J Med 2014; 370: 1101-1110 plus Supplementary Appendices. DOI: 10.1056/NEJMoa1313984.
5. Mössner E, Brünker P, Moser S, et al. Increasing the efficacy of CD20 antibody therapy through the engineering of a new type II anti-CD20 antibody with enhanced direct and immune effector cell mediated B-cell cytotoxicity. Blood 2010; 115:4393−4402.
6. Niederfellner G, Lammens A, Mundigl O, et al. Epitope characterization and crystal structure of GA101 provide insights into the molecular basis for type I/II distinction of CD20 antibodies. Blood 2011; 118:358−367.
7. Alduaij W, Ivanov A, Honeychurch J, et al. Novel type II anti-CD20 monoclonal antibody (GA101) evokes homotypic adhesion and actin-dependent, lysosome-mediated cell death in B-cell malignancies. Blood 2011; 117:4519-4529.