Kailera Therapeutics is advancing a pipeline of weight loss medicines that mirrors Eli Lilly’s: an injectable GLP-1/GIP dual agonist like Zepbound, an oral GLP-1 like Foundayo and a triple-G therapy like retatrutide.

After a record-breaking $625 million IPO, Kailera Therapeutics will tread a relatively safe road as the biotech’s trifecta of obesity drugs follow in the footsteps of one of the industry’s leading weight-loss players.

“We view Kailera’s broad GLP-1-based pipeline as largely de-risked through clinical and commercial validation from competitor programs, especially those from Eli Lilly,” William Blair told investors in a Wednesday note.

Kailera’s lead asset is ribupatide, a dual agonist of the GLP-1 and GIP receptors, much like Lilly’s mega-blockbuster Zepbound. Kailera is also advancing a small-molecule GLP-1 pill called KAI-7535 and a “triple-G” agonist dubbed KAI-4729—assets that work similarly to Lilly’s recently approved Foundayo and investigational retatrutide, respectively.

Despite the high bar that Lilly has set in the obesity market, there remains a place for Kailera, William Blair contended, noting that the company’s medicines could provide “options for patients with various weight-loss goals and across the full treatment journey.”

Kailera made a huge splash last month when it went public with a $625 million raise—the largest biotech IPO haul in history, topping Moderna’s $600 million from late 2018. Kailera launched in October 2024 with $400 million in starting capital and ex-China rights to a clutch of weight-loss assets from China’s Jiangsu Hengrui. Before going public, the biotech in October 2025 brought in $600 million in series B proceeds.

Now trading on the Nasdaq, Kailera is “heading into a catalyst-rich period” with clinical updates on the horizon for all of its obesity programs, according to William Blair.

On Wednesday, for instance, the biotech announced the initiation of a Phase 2b study testing higher doses of injectable ribupatide, with data expected next year. Ribupatide is also entering a broad Phase 3 weight-loss program called KaiNETIC. Initial findings are slated for 2028.

Kailera on Wednesday also provided data for its weight-loss pill KAI-7535 from a Phase 3 diabetes study conducted by Chinese partner Hengrui. At 32 weeks, patients taking the drug saw a 1.40% to 1.68% decrease in HbA1c levels, a measure of blood average sugar concentrations over the last two to three months. Placebo comparators saw a 0.06% drop in HbA1c.

Hengrui will report Phase 3 data for KAI-7535 in obesity later this year, Kailera said.

As for the triple-G drug, the biotech reported a mean weight reduction of 16% at 12 weeks, as compared with 5.4% in placebo counterparts, based on data from a Phase 1 study conducted in China. Kailera plans to initiate an early-stage program for KAI-4729 outside China, with data expected next year—where it will face high expectations set by Lilly’s retatrutide. The Big Pharma’s asset earlier this month elicited 28.3% weight reduction over 80 weeks.

“We anticipate 2027 to be a catalyst-rich year” for Kailera, William Blair analysts told investors on Wednesday, adding that the biotech is “positioned to be a strong contender in the obesity market.”

The FDA will convene its vaccines advisory panel to discuss seasonal COVID-19 vaccines—a surprise move after Health Secretary and vaccine skeptic Robert F. Kennedy, Jr. overhauled a separate vaccine committee.

The FDA will convene its Vaccines and Related Biological Products Advisory Committee to discuss possibly updating COVID-19 vaccines to include the now-dominant XFG subvariant. The meeting will take place on Thursday, May 28.

The session will be a whole-day affair, during which the external experts will hear from the CDC and an independent working group from the World Health Organization, according to a draft agenda posted on the FDA’s website. The U.S. withdrew from the WHO in January.

Vaccine developers Moderna, Sanofi and Pfizer will also be at the meeting to present updates from their respective products, per the federal documents.

The FDA’s VRBPAC has convened several times over the years—once during the second Trump administration—to evaluate strain selection and vaccine formulation. During its May 2025 meeting, the vaccines advisory committee unanimously voted to recommend monovalent COVID-19 vaccines targeting the JN.1 lineage of the virus, according to a briefing document posted Tuesday.

But the latest data from the CDC show that the XFG subvariant has now become the dominant type of virus circulating in the U.S. “More than six years after its emergence, SARS-CoV-2 is evolving against an increasingly heterogeneous immune landscape,” the FDA’s briefing document reads, pointing to varying levels of virus exposure, vaccination adherence and waning immunity across the country.

The VRBPAC will be tasked with making a recommendation for a COVID-19 vaccine formulation against this backdrop, the FDA said. “All licensed manufacturers have indicated that they are prepared to produce an XFG vaccine for COVID-19 vaccines,” the agency added.

The COVID-centric meeting comes shortly after the resignation of former FDA Commissioner Marty Makary—a known critic of COVID-19 vaccines. In his first public interview as FDA chief in April 2025, he claimed that the agency downplayed the side effects of COVID-19 shots, leading to what he called the “epidemic of distrust” against the regulator.

A month later, he unwrapped a risk-based approach to approving COVID-19 vaccines, noting that moving forward, the regulator would focus on products for adults 65 and older and high-risk patients with underlying conditions. Makary penned this new risk-based framework with Vinay Prasad, former director of the Center for Biologics Evaluation and Research, and a similarly vocal critic of COVID-19 vaccines.

Late last year, Prasad wrote an internal memo—that was subsequently leaked—claiming that “at least” 10 children have died “because” of COVID-19 vaccines. “For the first time, the US FDA will acknowledge that COVID-19 vaccines have killed American children,” he wrote at the time. Detailed data from the agency have since shown that Prasad’s claims were overblown, and that no pediatric deaths have been definitively linked to the shots.

Prasad left the FDA at the end of April.

Health Secretary Robert F. Kennedy, Jr. is himself a major skeptic of vaccines. Last May, for instance, Kennedy removed COVID-19 shots from the regular immunization guidelines for healthy pregnant women and healthy children. A few weeks later, he emptied the CDC’s vaccines advisory panel in a move he said at the time was “necessary to reestablish public confidence in vaccine science.”

He has since reformed this group, called the Advisory Committee on Immunization Practices, filling it with experts who share his skepticism toward vaccines.

An FDA advisory committee recently voted against approving AstraZeneca’s oral SERD drug camizestrant for certain patients with advanced breast cancer. It is unclear when the new target action date for the drug will be.

Nearly a month after failing to secure the backing of an advisory committee for its application to use camizestrant as a first-line treatment option for patients with certain types of advanced breast cancer, AstraZeneca will have to wait on an FDA decision as the regulator has pushed back its action date for the oral SERD drug.

AstraZeneca in its Wednesday announcement did not disclose the length of the review extension or the new target action date. The pharma also did not specify a reason for the delay, only noting that the FDA needs more time “to review additional data requested to support” camizestrant’s application.

The FDA accepted camizestrant’s data package in July 2025, according to a company presentation that month, but AstraZeneca did not disclose a specific decision date for the asset at the time.

Camizestrant is an oral SERD drug that works by targeting disease-related receptors on cancer cells, in turn suppressing tumor growth. AstraZeneca is proposing to combine camizestrant with the AKT blocker Truqap to treat patients with HER2-negative, HR-positive breast cancer harboring an ESR1 mutation.

The pharma backed its application with data from the Phase 3 SERENA-6 trial, which demonstrated a 56% decrease in the risk of disease progression or death. But external FDA advisors last month declined to endorse camizestrant for approval after finding issues with how SERENA-6 was conducted, the lack of survival data and unclear benefit on patients’ quality of life.

Original story published May 1:

AstraZeneca’s breast cancer drug fails to earn backing of FDA advisory committee
A panel of independent advisors have recommended against approving AstraZeneca’s oral SERD drug camizestrant for certain breast cancer patients alongside a CDK4/6 inhibitor.

The issue, the panelists contended, lies with AstraZeneca’s study design. In the Phase 3 SERENA-6 trial, the pharma opted to switch patients to camizestrant or continue their current treatment schedules at the point of testing for mutations in the ESR1 gene. This is an early point to switch treatment, which usually happens upon disease progression.

The committee members worried that an approval could set a precedent for other drugmakers, prompting similar trial designs without necessarily having robust evidence that an earlier switch indeed results in survival gains.

“The data for changing the paradigm just isn’t there,” Stanley Lipkowitz, deputy director of the center for cancer research at the National Cancer Institute, said when explaining his ‘no’ vote.

“I do agree with the FDA’s concern that all the next trials will do exactly this with no evidence that it’s improving outcomes,” he continued. While noting that he is “very excited” about oral SERDs, he couldn’t “say that we should change fundamentally how we approach patients based on this data.”

“If there were an OS [overall survival] benefit, I would have voted yes,” Lipkowitz said.

Six of the outside experts voted against AstraZeneca, versus three that came down in support of approval. The panelists were asked to vote on whether camizestrant demonstrated a clinically meaningful benefit in patients who have HR+/HER2- metastatic breast cancer with an ESR1 mutation.

For Natalie Compagni Portis, the patient representative on the panel, her ‘no’ vote leaned more heavily on the lack of survival data, which she said could weigh heavily on the psychology of women with breast cancer. “I think it’s an exciting possibility that we could truly change the paradigm and be able to truly assure patients that treating earlier means either living better and/or living longer with metastatic breast cancer.

“But I really wonder if we are exploiting the hope of women with metastatic breast cancer,” she continued. “Without evidence of longer overall survival and . . . to have very sparse data on [quality of life], it really seems only speculation and hope.”

SERENA-6 showed that patients treated with the camizestrant regimen saw a 56% reduction in the risk of disease progression or death, according to data published in June 2025 in The New England Journal of Medicine. OS data remain immature.

“Importantly, the panelists expressed enthusiasm for the potential of biomarker technology and did not question cami’s underlying activity, but were unconvinced by the trial meriting a change in the treatment paradigm,” Leerink Partners wrote in a Thursday evening note. “The panelists’ concerns were focused on the trial design, its endpoints, and its ability to establish clinical benefit. This leaves the door open for other cami programs.”

AstraZeneca is developing camizestrant in several other treatment settings for breast cancer, including for frontline care.

The FDA raised similar concerns as its outside experts. In a briefing document published earlier this week, internal reviewers pointed out that “the treatment paradigm evaluated in SERENA-6 is new.”

“Currently, no drugs have FDA approval for switching treatment in patients based on detection” as opposed to at radiographic progression, the agency documents read. “It is unclear whether changing treatment at this earlier timepoint, prior to radiographic progression, results in long-term benefit.”

The FDA does not have to follow the advice of an adcomm, but typically aligns with the experts’ recommendations.

From Eli Lilly’s David Ricks to Pfizer Albert Bourla, the top five highest paid CEOs made a combined $157.8 million in 2025.

The top five highest paid CEOs in pharma totaled $157.8 million in 2025, a 24% increase from the year before. Eli Lilly’s high-flying chief executive David Ricks led the pack yet again.

Ricks’ compensation package was valued at $36.7 million—a 26% increase from the year prior. Below him is Johnson & Johnson’s Joaquin Duato with $32.6 million.

The top five CEOs received the bulk of their compensation in the form of stock awards, which are not immediately paid out. Base salaries ranged from $1.6 to $1.8 million.

Below, BioSpace profiles the top five highest paid CEOs in pharma.

1. Lilly’s David Ricks

2025 compensation: $36.7 million
YoY change: 26%
2024 rank: 1

The highest paid CEO by far, Eli Lilly’s Ricks spent 2025 doing a victory lap. His company’s market cap rose 37% over 2025, briefly reaching $1 trillion, becoming the first pharma to do so.

The bulk of Ricks’ pay came in the form of $23.3 million in stock awards. His base salary was $1.7 million.

Justifying the compensation, Lilly pointed to the company’s 45% revenue increase to $65 billion and an 86% increase in earnings per share to $24.41 apiece. Ricks also oversaw a vast clinical program that produced positive clinical data across 25 Phase 3 trials.

Ricks was one of pharma’s main figureheads as the industry responded to pressure from President Donald Trump to onshore manufacturing and lower drug prices in 2025. Ricks appeared at the White House alongside his rival, Novo Nordisk’s Mike Maziar Doustdar, in November 2025 after both companies agreed to drop the price of their competing GLP-1 drugs.

Lilly also put forward $22.7 billion in investments across the U.S., the Netherlands and India last year, with much of the future capacity dedicated to the company’s burgeoning weight loss portfolio.

Ricks spent some of Lilly’s GLP-1 cash with key 2025 deals including Verve Therapeutics, Scorpion Therapeutics, SiteOne Therapeutics and Adverum Biotechnologies. The company also expanded into AI technology—a field that has seen plenty of activity from the Indianapolis pharma this year, too.

On the sales side, Ricks has been pushing Lilly into direct-to-consumer marketing, with the company’s weight loss products being offered to patients for self-pay. While all this was going on, Ricks dipped into financial podcasts and was a high-flying guest on the conference circuit to discuss his leadership and Lilly’s limitless ambition.

It’s no doubt that, as Lilly breaks the pharma mold, the board is keen to keep Ricks happy at the helm.

2. Johnson & Johnson’s Joaquin Duato

2025 compensation: $32.6 million
YoY change: 33%
2024 rank: 2

For overseeing the largest healthcare company in the world, J&J’s Duato took home $32.6 million. He helped exceed operational goals and drive J&J to the top of the list of pharmas by revenue, with $94.2 billion for 2025. This value, of course, factors in all of J&J’s units, which includes medtech.

Duato’s pay package included $15 million in stock awards on top of $1.6 million in base salary. Because J&J exceeded expectations, Duato will see his salary increase to $1.75 million for 2026.

The board noted in the proxy report that Duato’s work to overcome J&J’s looming patent cliff, strategic deals, talent development and succession planning and advancing the company’s R&D portfolio.

Duato’s work to overcome J&J’s looming patent cliff, strategic deals, talent development and succession planning, and advancing the company’s R&D portfolio were cited as reasons behind the robust pay package, the board noted in the proxy report.

J&J faced the same policy pressures as Lilly, but the company held off on reaching a Most Favored Nation deal until January of this year. Duato spoke out against the Trump administration’s manufacturing policies, urging the president to adopt tax policy changes instead. Nevertheless, J&J did announce $55 billion in new and expanded U.S. investments.

3. AbbVie’s Robert Michael

2025 compensation: $32.5 million
YoY change: 76%
2024 rank: 11

AbbVie once had pharma’s best-selling drug in Humira. But that inflammation and immunology heavyweight is now essentially forgotten as CEO Robert Michael and his team have raised Skyrizi and Rinvoq up in its place.

Michael took the helm in July 2025 from long-time CEO Rick Gonzalez. After his first full-year as chief executive, it seems the board—which he now chairs—is satisfied with its leadership choice.

While Michael helped AbbVie deliver on growth, the board rewarded him with a 76% increase in his compensation package. His base salary was on par with his peers at $1.7 million while his stock options were valued at $13.2 million. Michael’s higher pay for 2025 reflects his rise to board chairman and a one-time pay out in retirement benefits upon his 55th birthday.

Michael has ascended from the No. 11 spot of the highest paid pharma CEOs to No. 3.

Like his peers, Michael has been under pressure from the U.S. government to boost manufacturing. The company has committed $100 billion in R&D and capital investments for the next decade, the CEO said on the company’s first quarter earnings call.

Michael has overseen a number of business transactions, too. On the earnings call, he pointed to Capstan Therapeutics as a way to rebuild AbbVie’s immunology powerhouse beyond Skyrizi and Rinvoq.

“We have a tremendous amount of confidence given our long-term experience here,” said the 30-year veteran, who served at Abbott before the company split off the therapeutics division into what is now known as AbbVie. “We obviously have a commercial powerhouse, but I’d say our R&D organization understands the space very well.”

4. Gilead Sciences’ Daniel O’Day

2025 compensation: $28.4 million
YoY change: 20%
2024 rank: 5

The strong performance of Gilead Sciences’ HIV portfolio, led by record sales of Biktarvy, helped Daniel O’Day secure a 20% pay increase for 2025. The CEO’s compensation package was $28.4 million, just shy of his peers in the $30 million club.

O’Day received $1.8 million in base salary and $15.2 million in stock awards for 2025.

Gilead’s Yeztugo has also made a splash, securing initial approvals for pre-exposure prophylaxis. Analysts at the time heralded the approval as a major moment for the treatment and prevention of HIV.

In oncology, Gilead has been preparing to launch Trodelvy in more indications including first line metastatic triple-negative breast cancer. Anito-cel has also been submitted for advanced multiple myeloma with an FDA decision date in December.

“Gilead advanced the most robust pipeline in its history in 2025,” according to the company’s proxy statement.

5. Pfizer’s Albert Bourla

2025 compensation: $27.6 million
YoY change: 12%
2024 rank: 2

Pfizer’s chief executive Albert Bourla has fallen down the list of highest paid CEOs despite commanding a compensation package of $27.6 million. This represents a 12% increase over 2024—far less than the pay jumps enjoyed by many of Bourla’s peers.

Pfizer is undergoing a massive restructuring to prepare for looming loss of exclusivity for key products. 2025 was a year of rebuilding, with the business development team executing a number of high-profile deals—chief of which was the nearly $10 billion acquisition of weight loss biotech Metsera.

That’s because Novo Nordisk tried to swoop in with a better bid. Bourla was forced into the spotlight, with public and legal jabs thrown around as the two companies battled it out for the young—but promising—biotech.

Pfizer needed the deal badly. After initially trying to join the GLP-1 race using in-house assets, the company’s efforts stumbled in the clinic. To keep pace, Pfizer had to buy, and Bourla wanted Metsera.

This wasn’t the only time in 2025 that Bourla was thrust into the limelight. He also headed to the White House—the first of his pharma peers to do so in response to the Most Favored Nation drug pricing scheme—to secure a deal with the Trump administration.

Despite appearing chummy with the administration, earlier this year Bourla directed criticism at U.S. Health Secretary Robert F. Kennedy Jr.’s policies on vaccines. He said Pfizer’s drug pricing and oncology drug development discussions had been fine with HHS under Kennedy, but “it’s a different world when you start discussing vaccines. . . . There’s almost like a religion there.”

Still, Bourla leads one of the world’s most prominent pharma companies. He received a base salary of $1.8 million and stock awards valued at $9.4 million. His option awards were the highest of the group at $9 million.

Bourla has led the New York pharma since 2019, the year before the pandemic changed the world—and Pfizer’s business. Asked if he will step aside anytime soon during a first quarter earnings call in early May, Bourla said he has more work to do.

“I was very proud [of] what we were able to achieve with COVID, but then if you’re spoiled with this feeling of satisfaction, you want to do it again,” the CEO said. “So I’m planning to do it again, and hopefully with cancer and obesity and vaccines this time.”

Strong science and early support are not enough on their own. Europe needs more capital depth, cross-border investor backing and a lighter policy framework to keep companies scaling at home, according to two venture capitalists.

Germany has the science, capital and talent to produce biotech champions, as demonstrated by the massive, recent M&A news of Tubulis GmbH. Still, Europe needs deeper funding pools, more open syndication and less restrictive capital and employment mandates to help those companies remain true to their European roots, while allowing global scale.

The country drew life science headlines after Gilead Sciences announced in April its acquisition of Tubulis, a private, Germany-based, clinical-stage biotechnology company developing next-generation antibody-drug conjugates. Deal terms included $3.15 billion in cash plus up to $1.85 billion in potential milestone payments.

Tubulis’ success is not unusual in the dynamic German science environment.

There is a strong link between academic centers and hospitals, plus a history of strong science in nucleotide chemistry, antibody engineering and gene editing, said Regina Hodits, the Munich-based managing director at Angelini Ventures. In addition, Germany also benefits from a wider life science tradition, including an established pharma, medtech, CRO and CDMO infrastructure, added Sofia Ioannidou, the Paris-based VC partner at Andera Life Sciences. Tubulis was an Andera portfolio company.

The heady combination means Germany allows for excellent science to be translated into companies because the ecosystem is already well-developed, they agreed.

Bavarian hub

The majority of German life science activity is in the state of Bavaria, with Munich as the hub. There are 540 biopharma companies alone in the region, according to the BioM biotech cluster that represents the region.

Munich thrives due to the concentration of universities and research institution, Ioannidou explained. They include Ludwig Maximilian University of Munich, the Technical University of Munich, Max Planck Institutes and biotech centers like the Innovations- und Gründerzentrum Biotechnologie (IZB).

In addition, pharma and biotech presence in the region–such as Roche Diagnostics, with one of the largest biotech locations in Europe and MorphoSys, before its acquisition by Novartis–fermented an innovative environment, Hodits said.

Munich also hosts a concentration of capital through locally based yet internationally active firms such as Wellington Partners and EQT Partners, alongside the presence of global VC firms such as Andera and Forbion. The ecosystem of science and funding in the same ecosystem bode well for innovation.

Besides Munich, Heidelberg and Berlin are important life sciences centers as well.

Strong domestic funding support

Outside of VC funding, strong early domestic support in Germany is attractive. “If I had to advise founders with regards to the public funding on where to go, Germany would definitely be a place,” Hodits said. Schemes include state-backed capital, grants and co-investment funds.

She names examples such as the Federal Ministry of Research, Technology and Space’s (BMFTR) GO-Bio initiative that supports life science researchers who are looking to go into business and the Exist grant program to improve the start-up climate at universities and non-university research institutions.

Co-investment funds include Bayern Kapital and NRW Bank, Hodits said. Germany’s High-Tech Gründerfonds (HTGF) is one of Europe’s largest seed investors, managing more than 2 billion euros in capital.

In addition to domestic programs, there are early stage life science investment funds like the Carma Fund, based in Munich and Frankfurt, and KHAN, based in Dortmund, Hodits noted.

They nurture the ecosystem but there is the need for more capital pools, Hodits said. Additional early funding would move the translation needle far enough to become institutional venture investments.

Local capital constraints

Despite the impressive backbone of German domestic financial opportunities, both Hodits and Ioannidou stressed that the best European companies are built with broad syndicates, not just local money.

To become true champions of European companies with a good anchor in Europe, it’s important to have strong VCs in the respective countries collaborate to bring firms to scale.

Both Tubulis and France-based ImCheck Therapeutics started with European investors and later brought in US capital, Ioannidou added. Firms need access to wider talent, clinical expertise and regulatory knowledge across Europe, rather than staying trapped inside one local ecosystem, Hodits said.

In that regard, Hodits explained the detriment of local investment stipulations that force capital to stay inside specific regions. This rationale fosters an investment culture based on allocation rather than on merit, which is a detriment to innovation and company creation. For Europe to thrive, it needs to remain open to the U.K., U.S., and Asian funding sources, because tighter internal regulation could restrain the ecosystem unfavorably, Hodits said.

To maintain the competitive edge

To have Germany produce more life science stories that stay rooted in Europe, the most important stimulus will be more growth capital for rounds beyond Series A and B, plus public initiatives that mobilize institutional investors, Ioannidou said. In laymen’s terms, that translates to large European funds that can support three-digit rounds. This would allow entrenched domestic success stories without them disappearing to the U.S. too early.

Some drives to foster this larger funding do exist in Germany, such as the WIN initiative , a public-private partnership coordinated by the federal government designed to bolster Germany’s start-up and scale-up ecosystem.

Hodits agreed, adding that Germany still needs better treatment of stock options, tax policy, employment law and talent mobility if it wants to stay competitive.

Treatment with the TROP2 ADC sac-TMT led to a 70% objective response rate and progression-free survival was “significantly improved” as compared to placebo—the second positive readout for the asset this week.

Merck’s Chinese partner Kelun-Biotech appears to have validated the use of a TROP2 ADC along with immunotherapy—specifically the best-seller Keytruda—in first line lung cancer, potentially setting a new treatment paradigm, analysts said.

But this indication will be tough to crack with plenty of competition looming, wrote Leerink Partners in a Friday morning note to investors.

Kelun revealed data from the Phase 3 OptiTROP-Lung05 study of sacituzumab tirumotecan (sac-TMT) in an abstract posted Friday ahead of the American Society of Clinical Oncology (ASCO) Annual Meeting, which will kick off on May 29 in Chicago. The ADC was tested in 413 Chinese patients who had previously untreated locally advanced or metastatic non-small cell lung cancer (NSCLC) with certain gene mutations. Sac-TMT was added to a regimen with Keytruda while the placebo group received the immunotherapy alone.

Treatment with sac-TMT led to a 70% objective response rate (ORR) and progression-free survival (PFS) was “significantly improved” as compared to placebo. Median PFS was not yet reached at the cutoff point of 10.5 months, while the group that received immunotherapy alone had a PFS of 5.7 months. Overall survival (OS) was immature but Kelun said the trend was positive.

This is the second positive readout for sac-TMT this week heading into ASCO, with Merck announcing on May 18 that the ADC demonstrated significantly better OS and PFS in patients with late-stage endometrial cancer.

Leerink was particularly impressed by the ORR rate in NSCLC, which “compares favorably” to chemo plus Keytruda. That combo achieved about 56%–58% in this population.

PFS was also strong in a subgroup of patients with high PD-L1 expression, which the firm said “confirms the superiority of the doublet over global standard-of-care” Keytruda.

The study also showed “impressive safety and low discontinuation rates,” according to Leerink.

Kelun reported that treatment-emergent adverse events grade 3 or under—severe but not immediately life-threatening side effects—occurred in more than half of patients who received sac-TMT. That’s compared to 31% of patients in the Keytruda-only group.

Plenty of competition

Leerink said the results “appear supportive of the broader TROP2 ADC + IO strategy in [first line] NSCLC . . . but this is a high bar.”

More details on the study will be showcased at the ASCO meeting—the largest gathering of oncologists in the U.S. Leerink said the discussion will get into the weeds on the true potential of the ADC-Keytruda combo. But still, the results are a positive for Merck, according to the analyst.

“For us, details in the abstract are sufficient to drive MRK upside of +5%, given sac-TMT is one of few internal programs broad enough to drive more certain growth through the Keytruda [loss of exclusivity] period and investors have been relatively lackluster about the program,” Leerink wrote.

The data release also had Leerink comparing other companies’ programs with readthrough to the ADC-immunotherapy clinical win. AstraZeneca’s Dato-DXd, for example, had a 55% ORR rate when added to Keytruda in the Phase 1b TROPION-Lung02 study—well short of the 70% rate put up by Kelun. The Daiichi Sankyo-partnered program also had higher discontinuation rates.

Leerink also considered Akeso’s ivonescimab, a China-developed asset that Summit Therapeutics is testing for the U.S. market. Ivonescimab is a VEGF-A/PD-(L)1 bispecific, rather than an ADC, but could compete with sac-TMT in the same lung indication. Leerink said the OptiTROP-Lung05 data is “neutral” for Akeso’s program, despite having higher PFS, ORR and overall survival as compared to the Phase 3 HARMONi-2 trial.

Merck is also developing a VEGF-A/PD-1 therapy called MK-2010, which could be paired with sac-TMT in a double or triple combination for first line lung cancer.

The U.S. pharma paired up with Kelun, a subsidiary of China-based Sichuan Kelun Pharmaceutical, in December 2022 with a massive licensing deal worth up to $9.3 billion. Merck nabbed seven ADC programs, with Kelun retaining rights to their development in China.

Besides lung and endometrial cancer, sac-TMT previously showed a survival benefit in gastric cancer.