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。
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。
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。
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。
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。
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。
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。