Mer ck carves out path in first-line ad vanced cer vi cal can cer with new FDA win for Keytru da jug ger naut

Mer ck在一线广告中开辟了道路,并为Keytru da jug ger naut赢得了新的FDA win

2021-10-14 06:00:06 ENDPOINTS NEWS


Mer­ck’s PD-1 block­buster Keytru­da has held a steady march in­to ear­li­er lines of ther­a­py, with cer­vi­cal can­cer next up on its check­list. Af­ter flash­ing win­ning da­ta as part of a chemo com­bo last month, Keytru­da now has the FDA’s green light in first-line pa­tients. The FDA on Wednes­day ap­proved a com­bi­na­tion of Keytru­da plus chemother­a­py with or with­out be­va­cizum­ab to treat first-line per­sis­tent, re­cur­rent or metasta­t­ic cer­vi­cal can­cer, mak­ing it the first PD-(L)1 check­point in­hibitor ap­proved in that set­ting. The agency based its re­view on da­ta from the KEYNOTE-826 study, which showed the Keytru­da-chemo com­bo cut the risk of death by 33% over chemo alone (p=<0.001), ac­cord­ing to da­ta un­furled at Sep­tem­ber’s ES­MO con­fer­ence. The Keytru­da arm post­ed a me­di­an OS of 24.4 months com­pared with 16.5 months for the chemo arm, Mer­ck said. Mean­while, Keytru­da al­so post­ed a me­di­an pro­gres­sion-free sur­vival of 10.4 months com­pared with 8.2 months for chemo (p=<0.001). Pa­tients in the Keytru­da co­hort post­ed a re­sponse rate of 65.9% com­pared with 50.8% for chemo alone, and a me­di­an du­ra­tion of re­sponse of 18 months com­pared with 10.4 months, re­spec­tive­ly. KEYNOTE-826 served a dual pur­pose for Mer­ck as both the grounds for Keytru­da’s move in­to first-line ad­vanced cer­vi­cal can­cer, a dis­ease with about 14,500 new di­ag­noses each year in the US, and a con­fir­ma­to­ry study for the drug’s pre­vi­ous ap­proval in the sec­ond line. Es­tab­lish­ing it­self as stan­dard of care in ear­ly lines of metasta­t­ic dis­ease has be­come par for the course for Keytru­da, but cer­vi­cal can­cer re­mains a hard nut to crack and the sec­ond lead­ing can­cer killer of women world­wide. Mean­while, Mer­ck has as­pi­ra­tions for bring­ing Keytru­da in­to the ad­ju­vant/neoad­ju­vant set­ting be­fore a pa­tient’s dis­ease ever pro­gress­es. Al­so at ES­MO this year, Mer­ck rolled out new Phase III da­ta show­ing Keytru­da cut the risk of re­lapse or death by 35% over place­bo (p=0.00658) in high-risk, stage II melanoma pa­tients who had pre­vi­ous­ly un­der­gone surgery to re­move their tu­mors. In Au­gust, Mer­ck earned the FDA’s nod for a reg­i­men of Keytru­da plus chemo in the neoad­ju­vant set­ting fol­lowed by ad­ju­vant Keytru­da so­lo in pa­tients with high-risk triple-neg­a­tive breast can­cer. The drug­mak­er has al­so flashed win­ning da­ta in ear­ly kid­ney can­cer. The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks. RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings. As Eli Lilly works to consolidate its internal and Loxo teams into an oncology powerhouse, the drug giant is putting high hopes on CDK 4/6 inhibitor Verzenio to help drive the portfolio into the future. Now, the drug has scored a paradigm-altering win in early breast cancer — but will a controversial companion diagnostic hamstring Lilly’s market plans? The FDA on Wednesday approved CDK 4/6 inhibitor Verzenio in combination with physician’s-choice endocrine therapy to cut the risk of relapse in patients with high-risk HR-positive, HER2-negative breast cancer, Lilly said in a release. While both Pfizer/BioNTech and Moderna are looking to administer boosters for their Covid-19 vaccines six months after the initial two-dose series, J&J — which has vaccinated about 15 million Americans so far with its one-shot vaccine — is taking a more unique approach with boosters. According to briefing documents released ahead of Friday’s FDA adcomm on the booster dose, J&J is calling for its boosters to be administered anywhere from two months to six months following the initial shot, depending on the strength of the immune responses. Paul Stoffels, the scientific lead behind J&J’s refresh of its hallowed Janssen unit and the creation of the company’s single-shot Covid-19 vaccine, will retire at the end of the year, joining CEO Alex Gorsky on the way out the door and setting up a new era of leadership at the industry’s biggest drugmaker. As the man most responsible for J&J’s hard pivot back into R&D over the course of the past decade, Stoffels was responsible for propping up an oncology R&D unit that ranks among the largest in the industry as well as driving J&J’s efforts across a broad range of therapeutic areas. When Mark Denison awoke this month to learn that another one of the drugs from his lab had proven effective against Covid-19, two thoughts rushed through his mind. “I was so excited to hear that it had this potential,” he said. “And then I thought: Our resistance work is more important than ever.” Denison, 66, is arguably the scientist most responsible for molnupiravir, the pill Merck announced last week cut the risk of hospitalization or death in newly diagnosed Covid-19 patients by 50%. It came to his Vanderbilt lab alongside another molecule known as 3a — or, as it was later rechristened, remdesivir —  in the years after the 2012 MERS outbreak, as Denison worked to identify drugs that could be deployed in the event of another deadly coronavirus spillover. CBER director Peter Marks praised Janet Woodcock’s work as acting FDA commissioner, and while noting that Biden needs to nominate someone to fill the role permanently by Nov. 16, he said he has “no idea” when that actually might occur. “Dr. Woodcock has been at the agency for over three decades and she, during that time, has proven herself to be a remarkably capable manager,” Marks said at the Alliance for Regenerative Medicine’s meeting Tuesday. “And she’s been managing as if she’s commissioner, unlike some previous acting [commissioners] who are afraid to actually do things. She doesn’t appear to be afraid to do things. I have not felt any different now from when we had a commissioner in place,” he added. Madhu Natarajan can trace his fascination with the idea of taking B cells and turning them into protein factories back 20 years, when he had his own lab at UT Southwestern. So when Natarajan, now the rare disease development head for Takeda, sat down for a meet-up with execs from Seattle-based Immusoft at the last in-person JP Morgan conference, they went straight into a brainstorming session. “That B cells can take up residence and do what they do for a long time,” says Natarajan, pumping out proteins and “leveraging it into a therapeutic context,” hits his sweet spot for discovery deals. And he was deeply impressed by what he heard. For the first time, the FDA on Tuesday authorized tobacco companies to market electronic cigarettes. Regulators authorized three products in a similar fashion as they would with pharmaceuticals, although this time it was for longtime tobacco company RJ Reynolds. The authorizations were for a vaping device and associated tobacco-flavored pods, with FDA saying the benefits in weaning longtime smokers off traditional cigarettes outweighed the risks of getting younger people addicted. The agency emphasized it is only authorizing products that taste like tobacco, rather than flavored pods more appealing to kids and teenagers, such as candy, mint and fruit. The WTO’s TRIPS Council is meeting today and tomorrow to discuss a Covid-19 vaccine IP waiver that remains divisive and unlikely to be adopted thanks to European opposition, but which proponents still think could unlock more vaccine doses for low and middle-income countries. Following the meetings this week, it’s expected there will be a better sense if some kind of waiver can be agreed to by December, Tahir Amin, an IP lawyer and co-executive director of I-Mak, told Endpoints News.
Merck的PD-1 Block-Buster Keytru-da已经稳步向Ear Li er系列进军,Cervi Cal Can Cer在其清单上的下一个位置。作为上个月化疗方案的一部分,凯特鲁达现在在一线药物上获得了美国食品和药物管理局的批准。 美国食品和药物管理局在周三的一天证明了一种关键技术和化学方法的结合,可以治疗一线患者,治疗或转移患者,将其作为第一个PD-(L)1检查点。 该机构基于KEYNOTE-826研究中的DaTa的观点,该研究显示,KeyTru-Da-Chemo Combo比单纯化疗降低了33%的死亡风险(P=<0.001),这与9月份的Da-Ta Unfured有关。 Merck说,Keytru-da部门的平均寿命为24.4个月,而化疗部门的平均寿命为16.5个月。与此同时,Keytru da also发布了一份10.4个月的无并发症短期报告,与8.2个月的化疗相比(P=<0.001)。《重点研究报告》公布了仅化疗一项的复发率为65.9%,比50.8%低,18个月的复发率比10.4个月的复发率低。 KEYNOTE-826为Merck提供了双重姿态,既是Keytru Da进入一线广告CerviCal Can Cer的理由,也是美国每年约14500个新Diag Nose的理由,也是该药物在SEC领域的前期研究。 对凯特鲁达来说,作为耳朵转移线上护理的斯坦达尔德,这是理所当然的,但这是一个难啃的硬骨头,也是世界范围内女性的头号杀手。与此同时,默克有必要把钥匙带到广告/新广告的舞台上。 因此,在今年的Esmo上,Merck推出了新的第三期Da Ta Shoing Keytru,Da将高风险的II期黑色素瘤患者的复发或死亡风险比Place Bo降低了35%(P=0.00658)。在最后,默克赢得了美国食品和药物管理局的认可,在具有高风险三倍乳房的人群中,Adjuvant Keytruda So lo提出了一项新的Keytruda+化疗的规定。毒品制造商在耳边闪现了赢宁达达,孩子们也可以。 由于负面情绪占据主导地位,生物技术板块已从2月份的高点稳步回落。新冠肺炎疫苗的成功大大增强了该行业的乐观情绪,使投资者敏锐地意识到生物制药研发引擎的潜力。但从今年年初开始,临床试验、监管和准入方面的挫折提醒投资者该行业固有的风险。 加拿大皇家银行资本市场(RBC Capital Markets)最近对投资者进行了调查,以了解市场的温度,这是专家/通才和只做多/多空投资策略的混合。进入下半年,投资者大多认为该行业被低估(49%),与上半年只有20%的人认为该行业被低估相比有了很大变化。大约41%的投资者现在认为,生物技术将在2021年下半年表现低于标准普尔500。尽管有这种观点,54%的人计划维持市场头寸,41%的人仍计划增持。 随着礼来公司努力将其内部和洛索团队整合成一个肿瘤学强国,这家制药巨头对CDK4/6抑制剂Verzenio寄予厚望,以帮助推动该组合进入未来。现在,这种药物在早期乳腺癌方面取得了改变范式的胜利--但礼来公司的市场计划会是一个有争议的诊断腿筋伴侣吗? 礼来在一份新闻稿中说,美国食品和药物管理局周三批准了CDK4/6抑制剂Verzenio与医生选择的内分泌治疗相结合,以降低高危HR阳性、HER2阴性乳腺癌患者的复发风险。 虽然辉瑞/生物技术公司(Pfizer/BioNTech)和莫德纳(Moderna)都希望在最初的两剂疫苗系列六个月后为他们的新冠肺炎疫苗注射助推器,但J&J--迄今为止已为约1500万美国人接种了一针疫苗--正在对助推器采取更独特的方法。 根据周五美国食品和药物管理局关于加强剂量的adcomm之前发布的简报文件,J&J呼吁根据免疫反应的强度,在首次注射后两个月至六个月内给药。 保罗·斯托菲尔斯(Paul Stoffels)将于年底退休,加入首席执行官亚历克斯·戈尔斯基(Alex Gorsky),在该行业最大的制药商建立一个新的领导时代。 作为过去十年强生艰难回归研发的最大责任人,斯托菲尔斯负责支撑一个肿瘤研发部门,该部门位居行业最大之列,并推动强生在广泛的治疗领域的努力。 当马克·丹尼森本月醒来时,得知他实验室的另一种药物被证明对新冠肺炎有效时,他脑海中闪过两个想法。 “听到它有这种潜力,我很兴奋,”他说。“然后我想:我们的抵抗工作比以往任何时候都重要。” 66岁的丹尼森可以说是对莫努匹拉韦负有最大责任的科学家。莫努匹拉韦是默克公司上周宣布的一种药丸,将新诊断的新冠肺炎患者住院或死亡的风险降低了50%。在2012年MERS爆发后的几年里,当丹尼森努力识别在另一种致命冠状病毒外溢的情况下可以部署的药物时,它与另一种被称为3A的分子--或者后来被重新命名为remdesivir--一起来到了他的范德比尔特实验室。 CBER主任彼得·马克斯(Peter Marks)赞扬了珍妮特·伍德科克(Janet Woodcock)作为美国食品和药物管理局代理专员的工作,并指出拜登需要在11月16日前提名某人永久填补这一职位,但他表示,他“不知道”这实际上可能发生在何时。 “博士。伍德科克已经在该机构工作了30多年,在此期间,她证明了自己是一名非常有能力的经理,“马克斯在周二的再生医学联盟会议上说。“她一直在管理,就像她是专员一样,不像以前的一些代理(专员)害怕真正做事。她似乎不害怕做事。我现在和我们有专员的时候没有什么不同,“他补充道。 Madhu Natarajan可以追溯到20年前,当时他在UT西南大学有自己的实验室,他对提取B细胞并将其转化为蛋白质工厂的想法非常着迷。因此,在最近一次摩根大通面对面的会议上,当现在是武田罕见疾病开发负责人的纳塔拉扬坐下来与总部位于西雅图的Immusoft的高管会面时,他们直接进入了头脑风暴会议。 “B细胞可以长期驻留并做它们所做的事情,”Natarajan说,泵出蛋白质并“将其利用到治疗环境中”,这击中了他发现交易的最佳位置。他所听到的给他留下了深刻的印象。 美国食品和药物管理局周二首次授权烟草公司销售电子烟。 监管机构以类似于药品的方式授权了三种产品,尽管这一次是针对长期烟草公司RJ Reynolds。 授权是针对一种汽化设备和相关的烟草味豆荚,FDA表示,让长期吸烟者戒掉传统香烟的好处超过了让年轻人上瘾的风险。该机构强调,它只授权味道像烟草的产品,而不是对儿童和青少年更有吸引力的调味豆荚,如糖果、薄荷和水果。 世贸组织的TRIPS理事会今明两天将开会讨论新冠肺炎疫苗知识产权豁免,该豁免仍存在分歧,由于欧洲的反对,不太可能被采纳,但支持者仍然认为,该豁免可能会为中低收入国家释放更多疫苗剂量。 知识产权律师、I-Mak联合执行董事塔希尔·阿明(Tahir Amin)告诉Endpoints News,在本周的会议之后,如果能在12月前同意某种豁免,预计会有更好的感觉。