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First monoclonal antibody for cancer treatment on way to market…
THE LANCET
SCIENCE AND MEDICINE
First monoclonal antibody for cancer treatment on way to market . . . said Grillo-Lopez. Half the responshould add to our armamentarium”, ders are still in remission a year after said panel chair Virginia Broudy therapy and the average duration of (University of Washington School of response is 9·2 months. Medicine, St Louis, MO, USA). IDEC-C2B8 treatIn its FDA submisment depletes B-cells sion, IDEC presented for up to 9–12 months, the results of a pivotal so the agent does have trial in which patients’ some mild toxicities response to IDECrelated to its action, C2B8 was compared said Grillo-Lopez. The with their response to side-effects, which previous therapies, occur most often with and with published the first antibody responses to fludarainfusion, include fever, bine and cladiribine. Straight to the target chills, hypotension, IDEC-C2B8 was asthenia, and bronchospasm. 85% of given by infusion once a week for a patients had such side-effects with month. 6% of the 203 patients in the the first dose, said the FDA. trial responded completely to treatSymptoms were relieved with oral ment, 41% showed a partial paracetamol and diphenhydramine. response. 78% of patients who had IDEC-C2B8 will be sold by previously had autologous boneGenentech in the USA and Roche marrow transplants responded but elsewhere. patients who had been resistant to previous chemotherapy fared less well—only 36% of them responded, Alicia Ault Science Photo Library
he development of monoclonal antibody therapeutics has been an uphill battle. Inevitably, patients react to the murine component of the antibody, rendering the cure worse than the disease. But so far, the primatised B-cell-depleting monoclonal antibody IDEC-C2B8 (Rituximab), is looking good. Designed by IDEC Pharmaceuticals (San Diego, CA, USA), IDEC-C2B8 was unanimously recommended for approval in late July by a US Food and Drug Administration advisory committee for treatment of patients with low-grade or follicular B-cell non-Hodgkin lymphoma (NHL) whose tumour has not responded to other therapies. Speaking at the advisory meeting, Antonio Grillo-Lopez (IDEC) reported that, overall, 48% of patients with late-stage NHL have responded to IDEC-C2B8 treatment —a rate similar to other therapies for NHL, he noted. “This is an agent we
T
. . . and an additional weapon against the side-effects of chemotherapy
A
lymphomas already undergoing chemotherapy. The patients were randomised to receive a high dose of IL-11 (50 g/kg), a low dose of IL-11 (25 g/kg), or placebo. 38% of the high-dose group did not need platelet transfusion, compared with 19% receiving the low-dose IL-11 and 7% taking placebo. For patients needing transfusions, those receiving high-dose IL-11 needed fewer transfusions—2·2 on average—than those taking placebo (3·4). A second trial was in 77 women with advanced breast cancer who were scheduled to undergo two courses of high-dose cyclophosphamide or doxorubicin. 68% of patients given IL-11 did not
need platelet transfusions, compared with 41% of patients taking placebo. Patients taking IL-11 who needed transfusions had 0·8 transfusions on average, compared with an average of 2·2 transfusions for control patients. However, the panel discounted these results, saying that at least eight women did not complete a second course of chemotherapy, as required in the protocol. The most common side-effects of IL-11 treatment were oedema and dyspnoea due to fluid retention. More than half of study patients reported both side-effects.
News in brief
bovine spongiform encephalopathy was first reported.
women, half of whom were taking HRT, indicate that HRT reduces arterial stiffness.
Latest nvCJD figures According to data released by the UK Department of Health on Aug 4, the number of deaths of definite and probable UK cases of new variant CreutzfeldtJakob disease (nvCJD) is now 20. One definite case of nvCJD is still alive. Speculation in the lay media has drawn attention to a potential clustering of the cases in Kent where
Arterial stiffness Hormonal effects on arterial stiffness may be responsible for the reduced risk of coronary heart disease in postmenopausal women using hormonal replacement therapy (HRT; J Am Coll Cardiol 1997; 30: 350–65). Total systemic arterial compliance and pulse wave velocity measurements in 26 premenopausal and 52 postmenopausal
US Food and Drug Administration advisory panel unanimously voted in late July that Genetics Institute’s (Cambridge, MA, USA) human recombinant interleukin-11 (IL-11, Neumega) was effective in the prevention of recurrent severe thrombocytopenia in patients with solid organ tumours or non-Hodgkin lymphoma who had had thrombocytopenia during previous rounds of chemotherapy. However, the panel voted 14–3 against the use of the drug as a preventive therapy during initial chemotherapy. Secondary prophylaxis was supported by a pivotal trial of 93 patients with solid tumours and
416
Alicia Ault
Early dementia diagnosis US National Institute of Aging researchers report in this month’s American Journal of Psychiatry that decreased cerebral glucose metabolism (detected by use of positron emission tomography) during brain stimulation may allow presymptomatic diagnosis of dementias.
Vol 350 • August 9, 1997
SCIENCE AND MEDICINE
First monoclonal antibody for cancer treatment on way to market . . . said Grillo-Lopez. Half the responshould add to our armamentarium”, ders are still in remission a year after said panel chair Virginia Broudy therapy and the average duration of (University of Washington School of response is 9·2 months. Medicine, St Louis, MO, USA). IDEC-C2B8 treatIn its FDA submisment depletes B-cells sion, IDEC presented for up to 9–12 months, the results of a pivotal so the agent does have trial in which patients’ some mild toxicities response to IDECrelated to its action, C2B8 was compared said Grillo-Lopez. The with their response to side-effects, which previous therapies, occur most often with and with published the first antibody responses to fludarainfusion, include fever, bine and cladiribine. Straight to the target chills, hypotension, IDEC-C2B8 was asthenia, and bronchospasm. 85% of given by infusion once a week for a patients had such side-effects with month. 6% of the 203 patients in the the first dose, said the FDA. trial responded completely to treatSymptoms were relieved with oral ment, 41% showed a partial paracetamol and diphenhydramine. response. 78% of patients who had IDEC-C2B8 will be sold by previously had autologous boneGenentech in the USA and Roche marrow transplants responded but elsewhere. patients who had been resistant to previous chemotherapy fared less well—only 36% of them responded, Alicia Ault Science Photo Library
he development of monoclonal antibody therapeutics has been an uphill battle. Inevitably, patients react to the murine component of the antibody, rendering the cure worse than the disease. But so far, the primatised B-cell-depleting monoclonal antibody IDEC-C2B8 (Rituximab), is looking good. Designed by IDEC Pharmaceuticals (San Diego, CA, USA), IDEC-C2B8 was unanimously recommended for approval in late July by a US Food and Drug Administration advisory committee for treatment of patients with low-grade or follicular B-cell non-Hodgkin lymphoma (NHL) whose tumour has not responded to other therapies. Speaking at the advisory meeting, Antonio Grillo-Lopez (IDEC) reported that, overall, 48% of patients with late-stage NHL have responded to IDEC-C2B8 treatment —a rate similar to other therapies for NHL, he noted. “This is an agent we
T
. . . and an additional weapon against the side-effects of chemotherapy
A
lymphomas already undergoing chemotherapy. The patients were randomised to receive a high dose of IL-11 (50 g/kg), a low dose of IL-11 (25 g/kg), or placebo. 38% of the high-dose group did not need platelet transfusion, compared with 19% receiving the low-dose IL-11 and 7% taking placebo. For patients needing transfusions, those receiving high-dose IL-11 needed fewer transfusions—2·2 on average—than those taking placebo (3·4). A second trial was in 77 women with advanced breast cancer who were scheduled to undergo two courses of high-dose cyclophosphamide or doxorubicin. 68% of patients given IL-11 did not
need platelet transfusions, compared with 41% of patients taking placebo. Patients taking IL-11 who needed transfusions had 0·8 transfusions on average, compared with an average of 2·2 transfusions for control patients. However, the panel discounted these results, saying that at least eight women did not complete a second course of chemotherapy, as required in the protocol. The most common side-effects of IL-11 treatment were oedema and dyspnoea due to fluid retention. More than half of study patients reported both side-effects.
News in brief
bovine spongiform encephalopathy was first reported.
women, half of whom were taking HRT, indicate that HRT reduces arterial stiffness.
Latest nvCJD figures According to data released by the UK Department of Health on Aug 4, the number of deaths of definite and probable UK cases of new variant CreutzfeldtJakob disease (nvCJD) is now 20. One definite case of nvCJD is still alive. Speculation in the lay media has drawn attention to a potential clustering of the cases in Kent where
Arterial stiffness Hormonal effects on arterial stiffness may be responsible for the reduced risk of coronary heart disease in postmenopausal women using hormonal replacement therapy (HRT; J Am Coll Cardiol 1997; 30: 350–65). Total systemic arterial compliance and pulse wave velocity measurements in 26 premenopausal and 52 postmenopausal
US Food and Drug Administration advisory panel unanimously voted in late July that Genetics Institute’s (Cambridge, MA, USA) human recombinant interleukin-11 (IL-11, Neumega) was effective in the prevention of recurrent severe thrombocytopenia in patients with solid organ tumours or non-Hodgkin lymphoma who had had thrombocytopenia during previous rounds of chemotherapy. However, the panel voted 14–3 against the use of the drug as a preventive therapy during initial chemotherapy. Secondary prophylaxis was supported by a pivotal trial of 93 patients with solid tumours and
416
Alicia Ault
Early dementia diagnosis US National Institute of Aging researchers report in this month’s American Journal of Psychiatry that decreased cerebral glucose metabolism (detected by use of positron emission tomography) during brain stimulation may allow presymptomatic diagnosis of dementias.
Vol 350 • August 9, 1997