Dive Brief:
简报：
Celcuity said Friday its experimental breast cancer drug succeeded in another part of an ongoing Phase 3 trial, positioning the company to seek broader approval of a treatment that’s already undergoing a regulatory review.
Celcuity公司周五表示，其试验性的乳腺癌药物在正在进行的第三阶段试验的另一部分中取得了成功，这使得该公司能够寻求更广泛的批准，该治疗方案已经在接受监管审查。
According to Celcuity, two- and three-drug combinations involving its therapy gedatolisib
根据Celcuity公司介绍，涉及其治疗药物gedatolisib的两药和三药组合
helped delay disease progression
帮助延缓疾病进展
compared to a regimen with Novartis’ targeted medication Piqray and hormone therapy. Celcuity tested those combinations in people whose tumors were driven by a mutation in the PIK3CA gene and said, without specifics, that treatment was associated with a “statistically significant and clinically meaningful improvement.” The results will be featured at the upcoming American Society of Clinical Oncology meeting, which begins on May 29..
与诺华公司的靶向药物Piqray和激素疗法的治疗方案相比。Celcuity在那些肿瘤由PIK3CA基因突变驱动的患者中测试了这些组合，并表示，尽管没有提供具体细节，该治疗与“具有统计学意义且临床显著的改善”相关。研究结果将在5月29日开始的美国临床肿瘤学会会议上展示。
Celcuity previously reported that gedatolisib appeared to
Celcuity此前报告称，gedatolisib似乎
help breast cancer patients without confirmed PIK3CA mutations
帮助未确认PIK3CA突变的乳腺癌患者
. The company has already filed for U.S. approval, and a decision is expected by July 17. Celcuity intends to submit the new data in a supplemental application that could expand use to include people with those mutations. Shares climbed more than 18% on Monday, pushing Celcuity’s market value past $7 billion..
该公司已经提交了美国审批申请，预计7月17日会有决定。Celcuity计划在补充申请中提交新数据，这可能会扩大使用范围，将那些突变的人群包括在内。周一股价上涨超过18%，推动Celcuity的市值突破70亿美元。
Dive Insight:
深入洞察：
PIK3CA alterations are involved in a wide variety of cancers and, notably, an estimated 40% of people with a breast tumor that’s hormone receptor positive, but negative for the protein HER2. That’s made them an increasingly popular target among drugmakers looking for medicines that can block their activity..
PIK3CA基因变异与多种癌症有关，值得注意的是，约40%的激素受体阳性但HER2蛋白阴性的乳腺肿瘤患者存在这种变异。这使得它们成为越来越多制药商的目标，这些制药商正在寻找能够抑制其活性的药物。
A few treatments, such as Piqray,
少数治疗方案，比如Piqray，
Roche’s Itovebi
罗氏的伊托韦比
and AstraZeneca’s Truqap, are already available. But all are associated with side effects, such as skin rashes, gastrointestinal issues and hyperglycemia, that can hinder uptake.
和阿斯利康的Truqap，已经上市。但所有这些药物都伴有副作用，如皮疹、胃肠道问题和高血糖，可能会影响其使用。
Celcuity is among
Celcuity 是其中之一
several
几个
companies
公司
looking to bring to market better treatments that are either more selective or potent. It’s already close to an approval, following Phase 3 data last July that showed gedatolisib combinations significantly delayed disease progression compared to two other established drug regimens.
致力于将更有效或更具选择性的治疗方案推向市场。在去年七月的第三阶段数据显示，gedatolisib联合疗法相较于其他两种已确立的药物方案显著延缓了疾病进展后，该药物已接近获得批准。
But investors and analysts have been watching for additional results from that same trial that specifically included people with confirmed PIK3CA mutations. A meaningful improvement in that cohort could yield a broader market opportunity for Celcuity and help the drug separate itself from other therapies..
但是，投资者和分析师一直在关注同一试验的更多结果，该试验特别纳入了经确认的PIK3CA突变患者。这一群体的显著改善可能会为Celcuity带来更广阔的市场机会，并帮助该药物区别于其他疗法。
Heading into the data readout, analysts generally expected positive findings. But the fact that the two-drug combination including gedatolisib hit statistical significance is “particularly notable,” wrote Jefferies analyst Maury Raycroft. The finding suggests at least a two- to three-month separation from the control arm, he predicted..
进入数据解读时，分析师普遍预期会得到积极的发现。然而，包含gedatolisib的两种药物组合达到统计学显著性这一事实“尤其值得注意”，Jefferies分析师Mauray Raycroft写道。他预测，这一发现表明与对照组相比至少有两到三个月的差异。
The newly disclosed inclusion of Celcuity’s data at ASCO also “bodes well for the magnitude of benefit” associated with treatment, wrote Leerink Partners analyst Andrew Berens. Presentations were first announced last month, suggesting ASCO may have let Celcuity submit its results after the deadline, he added..
Celcuity的数据在ASCO上的新披露也“预示着与治疗相关的益处的显著程度”，Leerink Partners分析师安德鲁·贝伦斯写道。他补充说，这些展示首次宣布是在上个月，这表明ASCO可能允许Celcuity在截止日期后提交其结果。
The meeting will be held from May 29 to June 2 in Chicago.
会议将于5月29日至6月2日在芝加哥举行。