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Summit Akeso ivonescimab improves survival in Harmoni-6 trial

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Summit Akeso ivonescimab improves survival in Harmoni-6 trial

Piotr Swat | Lightrocket | Getty Images

An experimental lung cancer drug from Akeso and Summit Therapeutics reduced the risk of death by 34% in a closely watched late-stage trial, according to results released Sunday.

When combined with chemotherapy, the drug kept people with squamous non-small-cell lung cancer alive for a median of four months longer than the standard combination of immunotherapy and chemotherapy, a result that was statistically significant, according to an abstract released Sunday ahead of a presentation at the American Society of Clinical Oncology’s annual meeting. The Phase 3 trial was conducted in China, and a global Phase 3 study is ongoing.

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“The fact that it shows an improvement in overall survival in a difficult-to-treat patient population is very encouraging,” said Dr. Suresh Ramalingam, executive director of the Winship Cancer Institute of Emory University. “I’m mindful of the fact that this trial was done exclusively in China, and that brings up the question of how do these data apply to patient populations outside of China, and that will require future investigations.”

Called ivonescimab, the bispecific antibody targets PD-1 — similar to Merck’s best-selling drug Keytruda —and VEGF — similar to Roche’s Avastin. It’s become the subject of intense debate in the oncology and investment communities. Some say ivonescimab and similar drugs could be a successor to Merck’s wildly successful cancer drug Keytruda, while others warn it’ll disappoint like other once-promising ideas such as drugs targeting TIGIT, an immune receptor.

The dueling narratives are reflected in the stock price of U.S.-based Summit Therapeutics, which licensed the rights to ivonescimab outside of China from Akeso. Shares of Summit have skyrocketed nearly 600% in the two years since Summit said ivonescimab more effectively controlled tumors than Keytruda in a separate China trial. The stock has slid in the past month over concerns the drug won’t be as effective in a global population.

Cancer drug targets

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  • PD-1: A protein that helps cancer cells hide from the immune system.
  • VEGF: A protein that promotes the growth of new blood vessels and can help cancer cells thrive.

Previous studies have showed ivonescimab can effectively control tumors, an endpoint known as progression-free survival. That’s typically not enough to seek approval from the U.S. Food and Drug Administration, which wants proof that cancer drugs can keep people alive longer. Older VEGF drugs that effectively controlled tumors struggled to improve survival, which raised doubts that ivonescimab’s early promise would hold.

In the Harmoni-6 trial being presented Sunday, ivonescimab combined with chemotherapy kept people alive for a median of 27.9 months versus 23.7 months for people who received a standalone PD-1 drug and chemotherapy, an improvement of four months.

“It’s not clear how meaningful that is,” said Dr. Deborah Doroshow, associate professor of medicine, hematology and medical oncology at the Icahn School of Medicine at Mount Sinai. “It’s certainly, it’s not two months, but it’s also not a huge difference, and I think in terms of whether or not living four months longer is meaningful absolutely depends on the person who is living it.”

People receiving immunotherapy in the control group lived an average of six months longer than expected, raising questions about whether the trial enrolled a representative patient population and whether the advantage of ivonescimab might be better than reported in the study, said Doroshow, who serves on the steering committee for the ongoing Harmoni-3 global trial of ivonescimab.

One possible reason for the discrepancy is that the study was conducted in China, where people have historically responded better to standalone PD-1 and VEGF drugs, said Emory’s Ramalingam. The only way to determine whether combining the two in one molecule produces different results for broader populations is to run additional studies in the West, he said.

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Until then, Ramalingam called the trial results “good news” for Chinese patients.

“There is a new approach in squamous cell lung cancer that extends survival by about four months, which is a substantial improvement given that this is a patient population where progress has come in small steps,” he said.

Summit plans to report progression-free survival results from squamous patients in the global Harmoni-3 trial in the second half of this year. It expects to share results from non-squamous patients in the first half of next year.

Kateryna Kon/science Photo Library | Science Photo Library | Getty Images

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One purported benefit of PD-1/VEGF-targeting drugs is the ability to give them safely to people with squamous lung cancer, a subset most commonly caused by smoking. These tumors tend to crop up near major blood vessels in the lungs, and blocking VEGF can prevent those blood vessels from repairing themselves, leading to potentially fatal hemorrhaging.

In the trial being presented Sunday, bleeding of any severity occurred in almost one-quarter of people in the ivonescimab group, twice as much as in the control group. Less than 3% of the cases were considered severe versus about 1% of people who received the PD-1 drug tislelizumab, according to slides that will be presented Sunday where the presenter describes ivonescimab’s safety as comparable.

More broadly, drugmakers and investors alike want to know whether PD-1/VEGF drugs will succeed Keytruda and similar drugs like Bristol Myers Squibb’s Opdivo as mainstay treatments. Checkpoint inhibitors like Keytruda have transformed the treatment of lung cancer and are now used in dozens of other cancers. Keytruda alone has 44 indications and generated more than $30 billion in sales for Merck last year.

Replacing Keytruda everywhere it’s used today and potentially expanding into new indications would create “a very large market,” said Leerink Partners analyst Daina Graybosch. That prospect has prompted a rush of dealmaking.

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Licensing deals involving PD-1 drugs reached $30 billion last year, nearly doubling the previous peak of $16 billion in 2017, a few years after Keytruda and Opdivo reached the market. Merck and Bristol Myers Squibb were part of the recent rush, with both companies signing potentially multibillion dollar deals for PD-1/VEGF drugs.

But it’s unlikely that ivonescimab and similar drugs will be as broadly used, said Ethan Smith, oncology director at Norstella, especially as they face more competition from other emerging drugs like antibody drug conjugates than Keytruda had when it entered the market more than a decade ago.

Data from one antibody drug conjugate from Merck and partner Kelun is also being presented this weekend at the ASCO meeting. The experimental drug cut the risk of tumor progression by 65% in a study of lung cancer conducted in China, according to an abstract released ahead of the meeting.

While Merck thinks there will be places for PD-1/VEGF drugs and is excited about the one it’s developing, the company doesn’t expect them to become the next Keytruda, said Dr. Marjorie Green, Merck’s head of global oncology clinical development.

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“It’s an exciting time in oncology,” said Green. “I never thought that we would be in a position in lung cancer to debate about which of the new therapies is the best because there just have not been a lot of advances. Keytruda has just been a cornerstone therapy and people are like, ‘What’s going to displace it?’ And I think it’s good news for people who are unfortunately diagnosed with lung cancer that we’re in position to say, you know what, there might be multiple options of things that we can do, and then hopefully add them together and help even more.”

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Alamos Gold: A Goldmine For Believers In Gold

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Economists said Milei would fail. Argentina’s numbers tell another story

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Economists said Milei would fail. Argentina's numbers tell another story

When Javier Milei entered the race to be Argentina’s president, 108 notable economists said his policies could be a disaster. Three years later, the maverick president continues to prove them wrong.

As Argentina’s new president in December 2023, Milei faced an ailing economy due to corruption, inflation, excessive money printing and a bloated government. At that time, inflation was running at 211%, and exports were just $5 billion for the month. And GDP shrank by 2.3% in the last quarter of the year, according to government data.

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A letter signed by 108 economists from around the world, that included Thomas Piketty and former Colombian Finance Minister Jose Antonio Ocampo, released before the 2023 election, warned that Milei’s economic platform was “fraught with risks that make them potentially very harmful for the Argentine economy and the Argentine people.” They also added in their letter that, “However, while apparently simple solutions may be appealing, they are likely to cause more devastation in the real world in the short run, while severely reducing policy space in the long run.”

Fast-forward to 2026, and things look a lot better. Inflation fell to 34% in April, and exports increased to almost $9 billion that same month. And GDP growth surged to 4.4% last year. “The fact is that Milei really knows his stuff,” Evan Ellis, research professor of Latin American studies at the US Army War College Strategic Studies Institute told FOX Business.

ARGENTINA’S MILEI ELIMINATES DEFICIT, HAILED AS MODEL FOR MUSK’S ‘DOGE’

Javier Milei

Argentina’s President Javier Milei gestures during a meeting with young people from the Industrial Entrepreneurs Forum of Paraguay (FEIP) organized by the Paraguayan Industrial Union (UIP) at the headquarters of the National Secretary of Sports in As (Daniel Duarte/AFP via Getty Images / Getty Images)

To make that economic bounce-back happen, Milei used policy levers similar to those President Ronald Reagan used when he took office in 1981. First, there was the so-called fiscal shock therapy. “Milei cut state subsidies, eliminated government ministries, which resulted in a primary surplus,” Pete Earle, senior director of research at the American Institute for Economic Research, told FOX Business.

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“The country curtailed the financing of fiscal deficits,” Earle said. “The government reset its exchange rate with an informal dollarization, eliminating organized labor unions, and began external engagement by reopening its capital markets, which would result in more competition, which would be better for everyone.” 

“He was that quirky combo that he knew both the theory of minimizing government and the need to maximize individual freedom. He didn’t do things because he wanted votes,” Ellis said.

Javier Milei

Then presidential candidate Javier Milei of La Libertad Avanza lifts a chainsaw next to Buenos Aires province governor candidate Carolina Piparo of La Libertad Avanza during a rally on Sept. 25, 2023 in San Martin, Buenos Aires, Argentina.  (Tomas Cuesta/Getty Images / Getty Images)

“While Milei ‘s economic policies have some similarities to Regan’s, he is quite different,” Javier Negre, owner of the La Derecha Diario newspaper, told FOX Business. Negre, who is close to Milei said “Reagan was more establishment; Milei is an outsider.”

Who is Milei as a person? He has a blunt approach when talking to people. “He is not polite,” Negre told FOX Business. “He’ll tell you what he thinks.” He is also a very hardworking President. “He’s a low-cost president and works 20 hours a day,” Negre said. “He’s always on the phone.”

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ARGENTINA’S JAVIER MILEI FLIPS INFLATION ON ITS HEAD EVEN AS POVERTY GROWS

Argentina’s economic rebirth was also aided by the U.S. Treasury’s $20 billion currency swap. The swaps helped stabilize Argentina’s currency because of its credibility. And in turn, that credibility attracted foreign investors and more competition. In the last quarter of 2025, capital inflows hit an all-time high of $18.8 billion.

Under Milei, capital markets were opened to international markets, and exports surged. Notably, Argentina’s oil production has grown to 882,200 barrels per day this year, up 32% from 667,000 barrels per day when Milei took office in December 2023. Likewise, natural gas production increased to 48,748 million cubic meters in 2025, up 11% from 43,985 million cubic meters in 2023, according to the Argentina Energy Information website.

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The bottom line of Milei’s economic policies is that they work and can benefit from a similar playbook and so make the world richer and better. Inflation collapsed, and that single change has fed into other things in a positive way,” Earle told FOX Business. “That’s one of the greatest gifts to the rest of the world, and they can see that it works; It’s all grossly positive.”

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J&J prostate cancer drug reduces risk of cancer spread and death in late-stage study

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Silicom: The Market Is Still Pricing In A Cycle That Already Ended (NASDAQ:SILC)

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Silicom: The Market Is Still Pricing In A Cycle That Already Ended (NASDAQ:SILC)

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Wail Shudar, M.S., is a quantitative investor and AI professional with over a decade of experience in the technology sector. A Harvard University alumnus with advanced degrees in Computer Science and Data Science, Wail possesses a deep technical understanding of the machine learning architectures and data ecosystems currently transforming the global economy. Professionally, Wail has spent 10+ years as an AI/ML specialist, providing him with the unique ability to distinguish between sustainable technological innovation and market hype. To complement his technical background, he is currently a CFA candidate, focusing on the integration of institutional-grade fundamental analysis with algorithmic rigor. Since 2015, he has successfully managed portfolios using data-driven systematic strategies, utilizing a “quantamental” approach that leverages big data to identify alpha in the technology and biotechnology sectors. On Seeking Alpha, Wail focuses on identifying high-growth stocks where AI-driven breakthroughs act as a primary catalyst for valuation expansion. His primary mission is to demystify complex technical sectors for the broader investing community. By translating intricate data science concepts into actionable investment theses, he provides readers with a systematic framework for navigating volatile growth markets. Wail aims to bridge the gap between Silicon Valley engineering labs and Wall Street valuation models, offering a technical edge to fundamental investors.

Analyst’s Disclosure: I/we have a beneficial long position in the shares of SILC either through stock ownership, options, or other derivatives. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

Seeking Alpha’s Disclosure: Past performance is no guarantee of future results. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. Any views or opinions expressed above may not reflect those of Seeking Alpha as a whole. Seeking Alpha is not a licensed securities dealer, broker or US investment adviser or investment bank. Our analysts are third party authors that include both professional investors and individual investors who may not be licensed or certified by any institute or regulatory body.

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