Patients with advanced bladder cancer whose disease has progressed during or after treatment with platinum-containing chemotherapy, can now access Tecentriq® (atezolizumab) via routine NHS funding in England and Wales.
The approval is based on the totality of evidence from the Phase II/III IMvigor210 and IMvigor211 studies, which demonstrated the clinical efficacy and safety of atezolizumab compared with therapies currently provided to patients in this setting.
IMvigor210 is an open-label, multicentre, single-arm Phase II study that evaluated the safety and efficacy of atezolizumab in people with locally advanced or metastatic urothelial carcinoma (mUC), regardless of PD-L1 expression. The study included two cohorts. The first cohort consisted of individuals who had not received a prior treatment and who were ineligible for cisplatin-based chemotherapy. The second cohort included patients whose disease had progressed during or following previous treatment with platinum-containing chemotherapy.
IMvigor 210 cohort two study results showed that patients who had previously been treated with platinum-containing chemotherapy (n=311) demonstrated a median overall survival of 7.9 months and indicated atezolizumab shrank tumours (objective response rate) in 15% of the patients.
IMvigor211 is a Phase III study of atezolizumab in patients with mUC whose disease progressed during or after treatment with a platinum-based chemotherapy.
While the study did not meet its primary endpoint of overall survival compared with chemotherapy in a particular sub-group of patients with high levels of PDL-1 (thought at the time of the study design to be a good predictor of atezolizumab benefit) the performance of atezolizumab was consistent with improving efficacy results seen in previously reported studies.
Atezolizumab demonstrated durable responses across all patient subgroups and clinical benefit versus chemotherapy in the intention to treat population, with 12-month overall survival of 39% vs 32% and a significantly longer duration of response (21.7 vs 7.4 months on chemotherapy).
The chemotherapy medicine used in the trial (vinflunine) outperformed protocol assumptions and thus atezolizumab did not demonstrate a significant efficacy difference but did demonstrate more favourable safety and much longer lasting responses than those produced by chemotherapy. The totality of data highlights a favourable benefit/risk profile for atezolizumab in mUC.
Atezolizumab is recommended if it is stopped at 2 years of uninterrupted treatment or earlier, or if the disease progresses and Roche (Basel, Switzerland) provides atezolizumab with the discount agreed in the patient access scheme. This provides clinicians and relapsed bladder cancer patients with an additional treatment option on the NHS.
“Bladder cancer affects around 10,000 people each year in the UK and in its advanced form leads to poor outcomes; with only 15% of patients surviving more than 5 years. Bladder cancer has been seriously neglected for a long time and until recently there has been no significant new treatment options for patients in over 30 years. We welcome this news for patients with advanced bladder cancer,” explained Allen Knight, Chairman of Action Bladder Cancer UK.