■这是两项研究的总结,这些研究着眼于潜在的新疗法的安全性和有效性,N-803(Anktiva),与非肌肉浸润性膀胱癌(NMIBC)患者的标准治疗卡介苗(BCG)。一项研究是1b期研究,该研究测试了在以前从未接受过BCG(未接受BCG)的NMIBC患者中增加N-803剂量与相同剂量的BCG的组合。另一项研究是N-803和BCG在NMIBC患者中的2/3期研究,这些患者的癌症未被BCG单独消除(BCGun反应)。
■在1b期研究中,9名参与者被分成3组,每组3名参与者分别接受100,200或400μgN-803剂量和标准50mgBCG剂量.在2/3阶段的研究中,一组(队列A)患有原位癌(CIS)疾病的参与者和另一组(队列B)患有乳头状疾病的参与者接受400μgN-803加50mgBCG治疗.还有一组C仅接受400μgN-803。每周一次将治疗直接递送到膀胱中,连续6周。
■N-803加BCG消除了所有9名BCG幼稚参与者的NMIBC,效果持久,参与者在8.3至9.2年内保持无NMIBC。根据2022年的报道,82名(71%)BCG无反应CIS病患者中的58名(71%)癌症被消除,并且效果也是持久的。重要的是,约90%的成功治疗参与者避免手术切除膀胱.在患有乳头状疾病的队列B参与者中,治疗后12个月,72人中有40人(55.4%)无癌。单独使用N-803仅对10名参与者中的2名有效。在两项研究中,发现N-803和BCG的组合与非常少的不良事件相关.根据2/3期研究的结果,美国食品和药物协会(FDA)批准使用N-803加BCG治疗BCG无反应的膀胱S伴或不伴Ta/T1乳头状病.临床试验注册:NCT02138734(1b期研究),NCT03022825(2/3期研究)。
将IL-15超激动剂N-803添加到BCG治疗中,在未接受BCG和BCG无反应的患者中消除非肌肉浸润性膀胱癌的成功率很高。具有持久的效果,使患者避免手术切除膀胱。
UNASSIGNED: This is a summary of two studies that looked at the safety and effectiveness of a potential new treatment, N-803 (Anktiva), in combination with a standard treatment bacillus Calmette-Guerin (BCG) for people with non-muscle invasive bladder cancer (NMIBC).One study was a Phase 1b study that tested increasing doses of N-803 in combination with the same dose of BCG in people with NMIBC who had never received BCG previously (BCG-naive). The other study is a Phase 2/3 study of N-803 and BCG in people with NMIBC whose cancer wasn\'t eliminated by BCG alone (BCGunresponsive).
UNASSIGNED: In the Phase 1b study, the nine participants were split into three groups of 3 participants who received a dose of 100, 200, or 400 μg N-803 along with a standard 50 mg dose of BCG. In the Phase 2/3 study, one group (cohort A) of participants with carcinoma in situ (CIS) disease and another group (cohort B) with papillary disease were treated with 400 μg N-803 plus 50 mg BCG. There was also a cohort C that received only 400 μg N-803. Treatments were delivered directly into the bladder once a week for 6 weeks in a row.
UNASSIGNED: N-803 plus BCG eliminated NMIBC in all nine BCG-naive participants and the effects were long-lasting, with participants remaining NMIBC-free for a range of 8.3 to 9.2 years.As reported in 2022, cancer was eliminated in 58 of 82 (71%) participants with BCG-unresponsive CIS disease and the effect was also long-lasting. Importantly, approximately 90% of the successfully treated participants avoided surgical removal of the bladder. In cohort B participants with papillary disease, 40 of 72 (55.4%) were cancer-free 12 months after treatment. N-803 used alone was only effective in 2 of 10 participants. In both studies, the combination of N-803 and BCG was found to be associated with very few adverse events.Based on results from the Phase 2/3 study, the U.S. Food and Drug Association (FDA) approved the use of N-803 plus BCG for the treatment of BCG-unresponsive bladder CIS with or without Ta/T1 papillary disease.Clinical Trial Registration: NCT02138734 (Phase 1b study), NCT03022825 (Phase 2/3 study).
Addition of the IL-15 superagonist N-803 to BCG therapy produces a high rate of success in eliminating non-muscle invasive bladder cancer in both BCG-naive and BCG-unresponsive patients, with long-lasting effects that allow patients to avoid surgical removal of the bladder.