Nuvectis Pharma CEO Says Increased Dose Intensity Needed To Drive More Efficacy From Ovarian Cancer Lead Drug
Nuvectis Pharma CEO Says Increased Dose Intensity Needed To Drive More Efficacy From Ovarian Cancer Lead Drug
All patients enrolled into the study failed at least two prior lines of systemic chemotherapy, including at least one prior platinum-based chemotherapy regimen, and most had also failed treatment with bevacizumab.Nuvectis Pharma, Inc. (NASDAQ:NVCT) stock is trading lower after the company reported data from the Phase 1b study evaluating NXP800 in patients with platinum-resistant ARID1a-mutated ovarian cancer.
Nuvectis Pharma, Inc.（纳斯达克：NVCT）股票在公司报告了关于评估NXP800在铂金耐药的ARID1a突变卵巢癌患者中进行的第十亿阶段研究的数据后，股价下跌。
Three dosing regimens have been evaluated in twelve patients (four patients were treated on a once-per-day dosing schedule, two with 75 mg/day and two with 50 mg/day.
在十二名患者中评估了三种给药方案（四名患者按照每日一次的给药方案治疗，其中两名每天75毫克，另外两人每天50毫克。
Subsequently, eight additional patients were treated with 50 mg/day on an intermittent dosing schedule of five days on / two days off, a dosing schedule implemented to mitigate thrombocytopenia).
随后，另外八名患者接受了50毫克/每日的间歇性给药方案，即每五天用药/隔两天休息，这种给药方案旨在减少血小板减少症）。
All patients enrolled into the study failed at least two prior lines of systemic chemotherapy, including at least one prior platinum-based chemotherapy regimen, and most had also failed treatment with bevacizumab.
所有参与研究的患者至少有两种化疗药物治疗失败记录，包括至少一种铂类化疗方案，大多数患者还曾未能对贝伐珠单抗治疗产生效果。
In eleven efficacy-evaluable patients, antitumor activity was observed with best responses, including one with an unconfirmed partial response and six patients with stable disease, including tumor shrinkage.
在十一位接受评估有效性的患者中，观察到抗肿瘤活性，包括一个部分缓解和六名肿瘤稳定的患者，包括肿瘤缩小。
The Phase 1b interim data reported earlier this year included four patients evaluable for safety, of which three experienced Grade 4 thrombocytopenia.
今年早些时候发布的10亿阶段的临时数据包括四名可供安全评估的患者，其中三名经历了4级血小板减少症。
Subsequently, in the eight patients treated with NXP800 using the intermittent dosing schedule (50 mg/day, 5 days on / 2 days off), the highest grade of thrombocytopenia observed was Grade 2 (one patient).
随后，使用间歇性给药方案接受NXP800治疗的八名患者（每日50毫克，每五天用药/隔两天休息）观察到的最高级别的血小板减少症为2级（一名患者）。
Other than thrombocytopenia, the most common treatment emergent adverse events included nausea, fatigue, vomiting, diarrhea and constipation, the majority of which being Grade 1-2.
除血小板减少外，最常见的治疗新发不良事件包括恶心、疲劳、呕吐、腹泻和便秘，其中大部分为1-2级。
Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis, said, "However, it is clear that we need to increase the dose intensity to drive more efficacy in the next set of patients. We are already enrolling patients into a cohort of up to 10-12 additional patients utilizing a regimen of 75 mg/day on an intermittent dosing schedule, which is expected to be the last cohort in this Phase 1b study. We expect to provide additional clinical data from the Phase 1b study in the second quarter of 2025."
Nuvectis的董事长兼首席执行官Ron Bentsur表示：“然而，很明显，我们需要提高剂量密度，以在接下来的一组患者中获得更多的功效。我们已经将患者分配到一个高达10-12名额外患者的队列中，采用每日75毫克的间歇剂量方案，预计这将是第10亿阶段研究的最后一个队列。我们预计将于2025年第二季度提供第10亿阶段研究的额外临床数据。”
The NXP800 development program for this disease was granted FDA Fast Track Designation, and NXP800 was granted FDA Orphan Drug Designation for ARID1a-deficient ovarian, fallopian tube, and primary peritoneal cancers.
NXP800针对该疾病的开发计划获得了FDA快速通道认定，并且NXP800针对ARID1a缺陷的卵巢、输卵管和原发性腹膜癌获得了FDA孤儿药物认定。
Price Action: NVCT stock is down 43.20% at $6.05 at last check Thursday.
股价走势：NVCt股票在上周四的最后一次检查时下跌了43.20%，报6.05美元。
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