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.（納斯達克：NVCT）股票在公司報告了關於評估NXP800在鉑金耐藥的ARID1a突變卵巢癌患者中進行的第十億階段研究的數據後，股價下跌。
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.
在十二名患者中評估了三種給藥方案（四名患者按照每日一次的給藥方案治療，其中兩名每天75毫克，另外兩人每天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).
隨後，另外八名患者接受了50毫克/每日的間歇性給藥方案，即每五天用藥/隔兩天休息，這種給藥方案旨在減少血小板減少症）。
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.
所有參與研究的患者至少有兩種化療藥物治療失敗記錄，包括至少一種鉑類化療方案，大多數患者還曾未能對貝伐珠單抗治療產生效果。
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.
在十一位接受評估有效性的患者中，觀察到抗腫瘤活性，包括一個部分緩解和六名腫瘤穩定的患者，包括腫瘤縮小。
The Phase 1b interim data reported earlier this year included four patients evaluable for safety, of which three experienced Grade 4 thrombocytopenia.
今年早些時候發佈的10億階段的臨時數據包括四名可供安全評估的患者，其中三名經歷了4級血小板減少症。
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).
隨後，使用間歇性給藥方案接受NXP800治療的八名患者（每日50毫克，每五天用藥/隔兩天休息）觀察到的最高級別的血小板減少症爲2級（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.
除血小板減少外，最常見的治療新發不良事件包括噁心、疲勞、嘔吐、腹瀉和便秘，其中大部分爲1-2級。
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的董事長兼首席執行官Ron Bentsur表示：「然而，很明顯，我們需要提高劑量密度，以在接下來的一組患者中獲得更多的功效。我們已經將患者分配到一個高達10-12名額外患者的隊列中，採用每日75毫克的間歇劑量方案，預計這將是第10億階段研究的最後一個隊列。我們預計將於2025年第二季度提供第10億階段研究的額外臨床數據。」
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針對該疾病的開發計劃獲得了FDA快速通道認定，並且NXP800針對ARID1a缺陷的卵巢、輸卵管和原發性腹膜癌獲得了FDA孤兒藥物認定。
Price Action: NVCT stock is down 43.20% at $6.05 at last check Thursday.
股價走勢：NVCt股票在上週四的最後一次檢查時下跌了43.20%，報6.05美元。
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譯文內容由第三人軟體翻譯。
