Dive Brief:

潜水简介：

An experimental drug from CG Oncology has driven bladder cancers into remission in about three-quarters of the people who received it in a Phase 3 trial, matching results the biotechnology company disclosed from a smaller number of study participants last year.

CG Oncology的一种实验性药物在3期临床试验中，约四分之三的患者膀胱癌缓解，这与该生物技术公司去年从少数研究参与者那里披露的结果相吻合。

CG previously said that 50 of 66 trial volunteers with non-muscle invasive bladder cancer had no detectable disease after receiving the drug, known as cretostimogene. On Friday, the company presented new data showing 79 of 105 had these so-called complete responses. CG additionally said that 29 of 35 participants followed for at least 12 months are still cancer-free, though another 22 still await further scans..

CG之前表示，66名非肌层浸润性膀胱癌试验志愿者中有50名在服用cretostimogene后没有发现疾病。周五，该公司公布的新数据显示，105人中有79人得到了这些所谓的完整回复。CG还表示，随访至少12个月的35名参与者中有29名仍然没有癌症，尽管另有22名仍在等待进一步的扫描。。

Among the most common side effects associated with cretostimogene were bladder spasms, frequent urination and blood in urine. Two patients had adverse events judged by study investigators as serious — clotting or inflammation in the bladder — but no participants discontinued treatment. CG will reveal final study results later this year, and could seek regulatory approval afterwards..

与cretostimogene相关的最常见副作用是膀胱痉挛，排尿频繁和尿中有血。两名患者的不良事件被研究人员判断为严重-膀胱内凝血或炎症-但没有参与者停止治疗。CG将于今年晚些时候公布最终研究结果，并可能随后寻求监管部门的批准。。

Dive Insight:

潜水洞察：

Non-muscle invasive bladder cancer — where cancer cells are only on the bladder’s inner lining, and haven’t yet spread further — is typically treated with a type of immunotherapy called BCG following a tumor resection.

非肌肉浸润性膀胱癌-癌细胞仅位于膀胱内层，尚未进一步扩散-通常在肿瘤切除后用一种称为BCG的免疫疗法进行治疗。

But those interventions don’t work for everyone, and according to CG, about half of those who respond see their cancers return, after which there are limited and more drastic options such as chemotherapy and surgical removal of the bladder.

但这些干预措施并不适用于所有人，根据CG的数据，大约一半有反应的人看到他们的癌症复发，之后有有限且更激烈的选择，如化疗和手术切除膀胱。

CG is one of several companies trying to expand on those options. Its drug, cretostimogene, is a type of immunotherapy known as an oncolytic virus. CG is testing the drug in different settings, touting its potential as the possible “backbone” of future drug combinations. An ongoing Phase 2 trial is evaluating cretostimogene alongside Merck & Co.’s immunotherapy Keytruda.

CG是试图扩大这些选择的几家公司之一。它的药物cretostimogene是一种被称为溶瘤病毒的免疫疗法。CG正在不同的环境中测试该药物，吹嘘其作为未来药物组合的可能“骨干”的潜力。正在进行的第二阶段试验正在评估cretostimogene和默克公司的免疫疗法Keytruda。

Results are expected at the American Society of Clinical Oncology meeting later this month..

预计本月晚些时候的美国临床肿瘤学会会议将取得结果。。

But CG faces competition. Since 2020, the Food and Drug Administration has approved Keytruda, a gene therapy from Ferring Pharmaceuticals and an immunotherapy developed by ImmunityBio. A Johnson & Johnson medical device that releases chemotherapy into the bladder is also in testing and has shown promising results.

但CG面临竞争。自2020年以来，美国食品和药物管理局已经批准了Keytruda，这是一种来自Ferring Pharmaceuticals的基因疗法和ImmunityBio开发的免疫疗法。强生公司的一种向膀胱释放化疗药物的医疗设备也在测试中，并显示出令人鼓舞的结果。

Additional results were to be presented at a medical meeting Friday as well..

其他结果也将在周五的医疗会议上公布。。

Still, Wall Street analysts and investors have been supportive of CG’s chances. The company in January raised $380 million in the sector’s largest initial public offering this year. In a February report, Cantor Fitzgerald analyst Josh Schimmer called the offering “one of the highest-demand investment opportunities I've seen,” citing the company’s study results, development plans and cretostimogene’s potentially long-lasting market exclusivity..

不过，华尔街分析师和投资者一直支持CG的机会。该公司1月份在该行业今年最大规模的首次公开募股中筹集了3.8亿美元。康托·菲茨杰拉德（Cantor Fitzgerald）分析师乔什·希默（Josh Schimmer）在2月份的一份报告中称，该公司的研究结果、发展计划以及cretostimogene潜在的长期市场排他性，是“我见过的需求最高的投资机会之一”。。

Cretostimogene profile “is very competitive, and the market is large enough to accommodate multiple entrants,” Schimmer wrote. He estimates the drug, if approved, can bring in more than $1 billion in peak yearly sales.

Schimmer写道，Cretostimogene简介“竞争非常激烈，市场足够容纳多个进入者”。他估计，如果该药物获得批准，每年的最高销售额将超过10亿美元。

The study results reported on Friday build on those findings and provide a more comprehensive look at how CG’s drug stacks up. The trial, BOND-003, is evaluating the drug as a monotherapy in people who haven’t responded to BCG therapy and are at “high risk” of a recurrence.

周五公布的研究结果以这些发现为基础，更全面地了解了CG的药物堆积情况。BOND-003试验正在对卡介苗治疗无效且复发“高风险”的人群进行单药治疗评估。

CG has now evaluated 105 of its 112 participants for efficacy, which CEO Arthur Kwan, in an interview, called “the largest dataset that we're aware of ever reported in this space.”

CG目前已经对其112名参与者中的105名进行了疗效评估，首席执行官Arthur Kwan在一次采访中称之为“我们所知的该领域有史以来最大的数据集”

The drug’s complete response rate at any time after therapy, its main study goal, has held at about 75% even with more patients enrolled. Kwan also pointed out that just over 92% of those who received CG’s drug didn’t need their bladders removed. Neither did any participant with a complete response.

该药物在治疗后的任何时间的完全缓解率（其主要研究目标）保持在75%左右，即使有更多的患者入选。关颖珊还指出，接受CG药物治疗的人中，有92%以上不需要切除膀胱。也没有任何参与者给出完整的回答。

The company intends to track bladder removals going forward..

该公司打算追踪膀胱切除术的进展。。

“Most patients will tell you that they’d rather avoid that and try something else, which is exactly why the FDA has taken such a keen interest in this population,” he said.

他说：“大多数患者会告诉你，他们宁愿避免这种情况，而尝试其他方法，这正是FDA对这一人群如此感兴趣的原因。”。

Kwan acknowledged the competition CG faces, as well as the fact that the numbers could shift as more scans are done on the study’s remaining patients.

关颖珊承认CG面临的竞争，以及随着对研究剩余患者进行更多扫描，数字可能会发生变化的事实。

But while comparing drugs across trials is difficult, he noted that the complete response rates for cretostimogene appear higher than what’s been observed in testing of Merck, Ferring and ImmunityBio’s therapies. CG is also now moving earlier in a person’s disease course, testing its therapy in patients with “intermediate risk” of recurrence..

但是，虽然很难在不同试验中比较药物，但他指出，cretostimogene的完全缓解率似乎高于默克公司（Merck）、费林公司（Ferring）和ImmunityBio公司（ImmunityBio）疗法的测试结果。CG现在也开始在一个人的疾病过程中进行早期治疗，对复发“中等风险”的患者进行治疗测试。。

“It’s just the beginning,” he said.

“这只是开始，”他说。