Safety, pharmacokinetics, and efficacy of belantamab mafodotin monotherapy in Japanese patients with relapsed or refractory multiple myeloma: DREAMM-11.

Belantamab mafodotin, a B-cell maturation antigen-targeting antibody-drug conjugate (ADC), was investigated in Japanese patients with relapsed/refractory multiple myeloma in Part 1 of the phase I DREAMM-11 study. Patients who had received ≥ 2 prior lines of therapy including a proteasome inhibitor and immunomodulatory agent were eligible. Eight patients received belantamab mafodotin monotherapy at 2.5 mg/kg (n = 4) or 3.4 mg/kg (n = 4) by intravenous infusion every 3 weeks on day 1 of each cycle until disease progression or unacceptable toxicity. Primary objectives were tolerability and safety, and secondary objectives included pharmacokinetics (PK) and efficacy. The most common Grade ≥ 3 adverse event was thrombocytopenia/platelet count decreased (2.5 mg/kg cohort, 100% [4/4]; 3.4 mg/kg cohort, 75% [3/4]), and no dose-limiting toxicities were observed. Ocular events, including keratopathy findings, were observed in most patients (2.5 mg/kg cohort, 100% [4/4]; 3.4 mg/kg cohort, 75% [3/4]) and were managed with dose modifications. All resolved within the study period. Overall response rates were 50% (2/4) in the 2.5 mg/kg cohort and 25% (1/4) in the 3.4 mg/kg cohort. Although PK profiles in Japanese patients varied, individual exposures overlapped with previous results in Western populations. Belantamab mafodotin monotherapy was generally well-tolerated and demonstrated clinical activity at both doses.

Role of general practice in the diagnosis of oral cancer.

The incidence of oral cancer is increasing in the United Kingdom. There is evidence that early diagnosis and effective treatment improve survival, but the poor 5-year survival rate (50%), which has not improved for several decades, has been attributed to advanced stage at presentation. To investigate the symptoms associated with cancer of the oral cavity and to explore the role of general practitioners (GP) in the identification and referral of patients, we sent 200 patients questionnaires on the route to diagnosis, symptoms, delay in presentation, and outcomes of consultations with their GP. Of 161 respondents, over half (56%) had been referred to secondary care by their GP and a third (32%) by their dentist. The most commonly reported symptoms were a mouth ulcer (32%), a lump in the face or neck (28%), and pain or soreness in the mouth or throat (27%). Fifteen per cent delayed presentation for more than 3 months. After consultation with a GP (n=109), 53% were referred to a specialist, 22% were referred for tests, 12% were told that their symptom was not serious, and 12% were treated for another condition. GPs have an important role in the identification and referral of people with oral cancer, and the clearly recognised symptoms identified in this study can be used to aid assessment and decision-making. Interventions to promote the prompt identification of oral cancer in general practice such as the opportunistic screening of high-risk patients may help to improve the poor survival rates.