Category: 3. Business

(Bloomberg) — Asian stocks are poised for a weak start Tuesday following a stagnant session for equities on Wall Street, as investors were cautious ahead of a packed week of economic data and corporate earnings.

Benchmarks in Tokyo, Hong Kong and Sydney were set to decline as the buoyant mood from the tariff deal between President Donald Trump and the European Union ran out of steam, even as hopes were bolstered for an extension of a China trade truce. The dollar steadied Tuesday after climbing the most since May. Treasuries edged lower.

The euro slid the most in over two months as European leaders defended the US deal as Germany voiced concerns. The S&P 500 briefly topped 6,400 to close little changed. Oil rose as Trump said he’d shorten his timeline for Russia to reach a truce with Ukraine.

In the run-up to the Aug. 1 US tariff deadline, traders will go through a raft of key data from jobs to inflation and economic activity. The big event comes Wednesday, when the Federal Reserve is expected to keep rates unchanged. Then there’s a string of big-tech earnings, with four megacaps worth a combined $11.3 trillion reporting results.

“This is about as busy as a week can get in the markets,” said Chris Larkin at E*Trade from Morgan Stanley. “This week could make or break that momentum in the near term.”

European capitals defended the trade deal struck with Trump while industry officials in Germany warned that the deal leaves the auto industry exposed and will make companies in Europe less competitive. Dutch Minister for Foreign Trade Hanneke Boerma said the deal was “not ideal” and called on the commission to continue negotiations with the US. 

Meanwhile, US and Chinese officials finished the first of two days of talks aimed at extending their tariff truce beyond a mid-August deadline and hashing out ways to maintain trade ties while safeguarding economic security.

“Whether we agree or not with the use of tariffs and the deals announced, we are getting the big ones out of the way which will allow American businesses to adjust and plan, for better or worse,” said Peter Boockvar at the Boock Report. “And we can now focus on how this all plays out.”

Separately, the US Treasury jacked up its estimate for federal borrowing for the current quarter to $1 trillion, mainly due to distortions from the debt limit. On Wednesday, the department will announce its plans for note and bond sales over coming months — which dealers widely see as staying unchanged.

Elsewhere in Asia, Trump said he had asked US officials to resume trade negotiations with Cambodia and Thailand after the countries agreed to halt fighting along a disputed border.

In Japan, Prime Minister Shigeru Ishiba is fighting to stay in power, and insisted he would stay on after some ruling party lawmakers stepped up their calls for his resignation following last week’s historic election setback.

The key for markets this week is a rate decision by the Fed. 

Chair Jerome Powell and his colleagues will step into the central bank’s board room for a two-day meeting starting Tuesday to deliberate on rates at a time of immense political pressure, evolving trade policy, and economic cross-currents.

In a rare occurrence, policymakers will convene in the same week that the government issues reports on gross domestic product, employment and the Fed’s preferred price metrics. Forecasters anticipate the heavy dose of data will show economic activity rebounded in the second quarter.

While the stock market is moving sideways after a solid run, “if we get no surprises in earnings and some dovish comments by the Fed, it’s likely we’ll see yet more new highs by the end of the week,” said Louis Navellier, chief investment officer at Navellier & Associates.

Some of the main moves in markets:

Stocks

• S&P 500 futures were little changed as of 8:31 a.m. Tokyo time
• Hang Seng futures fell 0.5%
• S&P/ASX 200 futures fell 0.7%

Currencies

• The Bloomberg Dollar Spot Index was little changed
• The euro was little changed at $1.1591
• The Japanese yen was little changed at 148.59 per dollar
• The offshore yuan was little changed at 7.1821 per dollar
• The Australian dollar was little changed at $0.6522

Cryptocurrencies

• Bitcoin was little changed at $118,051.89
• Ether rose 0.1% to $3,793.32

Bonds

• Australia’s 10-year yield was little changed at 4.34%

Commodities

• West Texas Intermediate crude rose 0.4% to $66.96 a barrel
• Spot gold fell 0.1% to $3,310.75 an ounce

This story was produced with the assistance of Bloomberg Automation.

©2025 Bloomberg L.P.

Sydney, 29 July, 2025 — FTI Consulting, Inc. (NYSE: FCN) today announced the appointment of Sabine Bennett as a Senior Managing Director in the Australian Healthcare & Human Services practice.

Ms. Bennett, who is based in Sydney, has more than 16 years of experience delivering large, complex, technology-enabled transformation programs for health, aged care and life sciences clients. In her role at FTI Consulting, she will bring her deep sector expertise to help clients strategise, design and deliver digital solutions that improve patient and clinician experience , while working side-by-side with clients to embed these solutions and unlock their full value.

“Sabine has an excellent track record of working with organisations to create seamless digital experiences for consumers, providers and regulators,” said Nathan Schlesinger, Leader of the Healthcare & Human Services practice in Australia at FTI Consulting. “Her strength lies in driving strategy to execution, delivering the right outcomes by putting people at the centre, while creating value for organisations.”

The Healthcare & Human Services industry practice focuses on supporting clients with key industry agendas including sector reform and sustainability, digital transformation and productivity. The practice launched in January 2025 and has continued to add talent to build an industry-oriented capability that complements existing FTI Consulting services in policy and economics, cybersecurity, financial sustainability, restructuring and risk-oriented services.

Commenting on her appointment, Ms. Bennett said, “Australian organisations have great ambitions around Digital and AI to thrive in current conditions, but the execution is often challenging. I am excited to be scaling a practice with the skills and expertise our country needs to lead and support organisations through this. I can’t wait to collaborate with my new colleagues as we work with health services and agencies to design and deliver digital solutions that work for patients, clinicians and communities.”

Prior to joining FTI Consulting, Ms. Bennett was a Partner and the Digital Health Leader at a Big Four firm in Australia. Prior to that, she worked at NTT DATA Business Solutions, an IT services and consulting firm.

About FTI Consulting
FTI Consulting, Inc. is a leading global expert firm for organisations facing crisis and transformation, with more than 7,900 employees located in 32 countries and territories as of June 30, 2025. In certain jurisdictions, FTI Consulting’s services are provided through distinct legal entities that are separately capitalised and independently managed. The Company generated $3.70 billion in revenues during fiscal year 2024. More information can be found at www.fticonsulting.com.

FTI Consulting, Inc. 
Level 22, Gateway
1 Macquarie Place
Sydney, NSW 2000
Australia

+61 2 8247 8000

Investor Contact: Mollie Hawkes
+1.617.747.1791
mollie.hawkes@fticonsulting.com

Media Contact: Rebecca Hine
+61 402 235 829

rebecca.hine@fticonsulting.com

Source: FTI Consulting, Inc.

Key Takeaways:

Recent Developments in the Asian Insurance sector:

• Hong Kong: The new Hong Kong redomiciliation regime for insurers has come into effect, enabling insurance companies to move their domicile to Hong Kong. This move is expected to enhance Hong Kong’s status as a leading international insurance hub.
• Mainland China: Regulatory authorities have relaxed the asset requirements for financial institutions from Hong Kong and Macau wishing to invest in Mainland Chinese insurers. This change exemplifies China’s efforts to further open up its financial services sector and expand the pool of investors eligible to invest in Chinese insurance companies.
• India: The foreign ownership limit in the Indian insurance industry will be increased from 74% to 100%, subject to implementing legislation that is expected to be passed later this year. This is a highly anticipated milestone for the liberalisation of the Indian insurance industry and is expected to result in increased M&A activity in the sector.

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Hong Kong: Redomiciliation Regime for Insurers Becomes Effective

Introduction

On 23 May 2025 the new Hong Kong redomiciliation regime for insurers became effective through amendments to the Companies Ordinance, Insurance Ordinance and other laws and guidelines.

Before an overseas-based insurer with a Hong Kong branch approaches the Insurance Authority (the “IA”) with a redomiciliation proposal, it should consider the legal and regulatory position in its jurisdiction of incorporation and the jurisdictions where any other branch offices are located. For a redomiciliation to be feasible, the jurisdiction of incorporation must have an outwards redomiciliation regime. Such a regime is available in Bermuda and a number of U.S. jurisdictions but not in certain other jurisdictions.

Overseas insurers that do not currently have an authorised Hong Kong branch need to undergo a full authorisation process with the IA and a redomiciliation will only be feasible once full authorisation—or at least an authorisation in principle—has been achieved.

Initial Analysis

In relation to other existing branches of insurers considering redomiciliation, it is important to carry out a full analysis of whether the law and regulations of the jurisdiction where the branch is located will recognise the redomiciliation in the sense that the branch will simply be treated as a branch of the redomiciled entity after completion of the redomiciliation.

While a number of jurisdictions recognise redomiciliations, mergers and other corporate transactions and will likely facilitate the re-registration of the branch in this way, others may require a regulatory approval or even a new authorisation process for the redomiciled entity.

If the insurer has written insurance business from its jurisdiction of incorporation, the conversion into a regulated branch upon redomiciliation would also need to be discussed with the local regulator.

The insurer should carry out an assessment of whether the redomiciliation would have any adverse effects on policyholders, such as in relation to the tax treatment of policies, and discuss any material adverse implications with relevant regulators.

An assessment will need to be carried out on whether the insurer will be able to comply with all relevant Hong Kong laws and guidelines immediately after the redomiciliation. In most cases, this should not be a major concern since many insurers contemplating redomiciliation are already required to comply with such rules and regulations as “designated insurers”. The IA has provided additional guidance on the application of certain guidelines to redomiciled insurers, and new provisions in the Insurance Ordinance ensure that key persons approved by the IA in relation to the insurer before the redomiciliation will be deemed approved by it after redomiciliation.

However, for insurers who do not currently write most of their business in Hong Kong, a gap assessment should be carried out, and any changes that are required should be factored into the timetable.

Given the implications of the above processes for the overall timing of the redomiciliation, seeking legal advice in the relevant jurisdictions and discussing the proposal with local regulators at an early stage are key to a successful redomiciliation.

From a contractual perspective, it should be assessed whether the redomiciliation would result in any termination rights or other adverse consequences under material contracts, including reinsurance treaties.

Redomiciliation Process

Once the preliminary analysis has been completed, the proposal and timelines should be discussed with the IA at an initial meeting. Following guidance from the IA, the insurer can then apply to the IA for a letter of non-objection to the redomiciliation. The IA has made available an application form for this purpose on its website. Key elements of the application are the steps to be undertaken in relevant jurisdictions, as supported by legal opinions where applicable; any material adverse effects on policyholders; and the communication plan in relation to policyholders.  

Based on the timetable devised for the transaction, the insurer will also need to make relevant applications and submissions to the other regulators involved in the process. The IA expects insurers to provide a reasonable time for policyholders to raise enquiries, to deal with such enquiries promptly and to keep the IA informed of material concerns. Communications with policyholders of the head office and branch offices will have to be carefully coordinated, taking into account any local requirements.

Once the IA issues its letter of non-objection, the insurer can apply to the Companies Registry in order to be issued a certificate of redomiciliation. This final step should be a formality if all required steps have been completed in the relevant jurisdictions.

Once the certificate of redomiciliation is issued, the insurer will be expected to comply will all relevant Hong Kong laws and regulations and will need to update relevant websites, terms and conditions and policy materials as appropriate. The insurer will then need to complete the deregistration in its jurisdiction of incorporation in accordance with the requirements of the Companies Ordinance.

Hong Kong law does not regard the redomiciled insurer as incorporated in Hong Kong following the redomiciliation; rather, it treats the insurer as having changed its domicile to Hong Kong, while its jurisdiction of incorporation remains unchanged. Given the insurer’s deregistration in its jurisdiction of incorporation, this distinction should have little practical effect since the insurer will no longer be subject to the company law of such jurisdiction of incorporation.

Overall, the redomiciliation process may be fairly straightforward for insurers that are currently based in Bermuda and have no other overseas branches or operations outside Hong Kong, while those with multiple overseas branches will likely require more detailed analysis and coordination in order to ensure that the regulatory process can be completed smoothly in all relevant jurisdictions.

China Relaxes Asset Requirement for Hong Kong and Macau Financial Institutions Investing in Mainland Insurers

On 26 February 2025, the National Financial Regulatory Administration of China (the “NFRA”) issued a notice on matters relating to investment in insurance companies by Hong Kong and Macau financial institutions (the “NFRA Notice”), according to which, starting from 1 March 2025, a Hong Kong or Macau financial institution would no longer be required to have total assets of US$2 billion or more at the end of the most recent year to invest in mainland insurance companies. This requirement remains applicable to other overseas financial institutions investing in Chinese insurance companies.

The removal of such total assets requirement for Hong Kong and Macau financial institutions, which marks part of China’s efforts to deepen opening up in its financial services sector and expand the pool of investors eligible to invest in Chinese insurance companies, follows agreements signed in October 2024 between Mainland China and Hong Kong, as well as between Mainland China and Macau, to revise the Agreement on Trade in Services under the Mainland and Hong Kong Closer Economic Partnership Arrangement (“CEPA”) and CEPA between Mainland China and Macau. The following qualification requirements on Hong Kong and Macau financial institutions investing in mainland insurance companies remain unchanged under CEPA:

• a good and stable financial condition with continuous profit-making record for the recent three consecutive accounting years;

• a long term credit rating of A or above from international credit agencies in the last three years;

• no records of significant violation of laws and regulations for the last three years; and

• having fulfilled the requirements of prudential supervision standards of the financial regulators where they are domiciled.

While the NFRA Notice and CEPA provide a window of opportunity for Hong Kong and Macau financial institutions to gain greater access to the Chinese insurance market, there are some other qualification requirements under NFRA rules that generally apply to investors in Chinese insurance companies, including the various requirements under the Administrative Measures for Equity Interests in Insurance Companies for financial shareholders, strategic shareholders or controlling shareholders of Chinese insurance companies.

Increase in Foreign Ownership Limit to 100%—an Important Milestone for the Indian Insurance Industry

In February 2025, the Indian government announced that the foreign ownership limit for the insurance sector would be increased from 74% to 100% (the “New FDI Limit”). This is a highly anticipated milestone for the liberalisation of the Indian insurance industry and is expected to result in increased M&A activity in the sector. However, the new limit will not take effect until revised legislation and regulations reflecting the change have been put in place.

Implementation

In order for the New FDI Limit to come into effect, the Insurance Act, 1938 (the “Indian Insurance Act”) will need to be amended, which requires the approval of both houses of the Indian Parliament and presidential assent followed by publication in the official government gazette. It is expected that the amendment bill will be tabled in the current monsoon session of Parliament, which ends in late August 2025. The passage of the bill is expected to be smooth given the parliamentary majority commanded by the incumbent government.

The operating rules on foreign investment in the insurance sector and Indian exchange control rules applicable to this sector will also require amendment. New draft rules have not been published so far, but it is hoped that these will be finalised soon.

Key Questions

There are a few points of detail on which the draft regulations are expected to shed light, for instance, whether the Insurance Regulatory and Development Authority of India (“IRDAI”) will relax the requirement regarding the majority of directors, key management personnel and at least one amongst the board chairperson, managing director and chief executive officer being resident Indian citizens, in the context of insurers with foreign investment.

The government’s announcement also refers to the New FDI Limit applying to insurers that invest the entire premium in India. Currently, premiums collected by Indian insurers are classified as “policyholder funds” and the law already restricts the investment of such funds outside India, either directly or indirectly. Therefore, a key question is whether the regulations will impose any further requirements in this regard.

Also, realised profits are transferred to “shareholder funds”, from which dividends are declared. Although there are currently no specific investment restrictions on shareholder funds, it is uncertain whether incremental conditions or clarifications will be introduced to align with the Indian government’s announcement.

The government also announced simplification of conditionalities associated with foreign investment without providing details on the specific changes envisaged. However, any simplification will be welcomed by international investors and this “investor friendly” messaging is also consistent with the current approach adopted by the IRDAI.

The public consultation process leading up to the announcement of the New FDI Limit also contemplated a new composite licence for life and non-life insurance business under a single licence (as opposed to standalone licences for each of life, general and health insurance). The government has not indicated whether such a change will be introduced together with the New FDI Limit, or at all, and it is expected that the government’s position on this issue will become clearer once legislation on the New FDI Limit is tabled. Allowing for a composite licence would likely add to the attractiveness of the Indian insurance market for foreign investors, although much will depend on the requirements and implications of such a composite licence.

Implications for Foreign Investment

Since the foreign investment limit was increased from 49% to 74% in 2021, there was significant interest from foreign investors in the Indian insurance market, and a number of foreign insurers with existing joint ventures in India increased their ownership stake. However, for many foreign insurers and investors, the need to pair up with a local partner has not been an attractive proposition, and hence new market entries of international insurers and other investors have been limited.

The ability of foreign investors to purchase 100% of an Indian insurer or set up a wholly owned greenfield operation with an experienced management team is likely to result in a significant increase in foreign investment in the Indian insurance sector. For instance, foreign private equity investors have historically required a local partner with a 26% stake to support a local management team, and the IRDAI has been hesitant in allowing professional management teams without substantial independent financial backing to satisfy this requirement. With the New FDI Limit, the hope is that such investors can now enter the sector more easily without relying on a domestic partner.

The new limit will also result in existing foreign investors strategically considering whether to buy out their Indian partners. The terms of existing shareholders’ agreements and the commercial importance of the joint venture partner will be key considerations in this regard.

 

 

This publication is for general information purposes only. It is not intended to provide, nor is it to be used as, a substitute for legal advice. In some jurisdictions it may be considered attorney advertising.

July 28 (UPI) — Twenty national security experts and former government officials are urging the Trump administration to reverse a decision earlier this month to let Nvidia resume selling H20 AI chips in China.

They wrote a letter Monday to Commerce Secretary Howard Lutnick, saying that the decision announced two weeks ago was a “strategic misstep that endangers the United States’ economic and military edge in artificial intelligence (AI) — an area increasingly seen as divisive in the 21st-century global leadership.”

The signees include seven officials in government, including the National Security Agency, Homeland Security and the Defense Department.

H20’s AI is the process of using an AI-trained model to make decisions on unseen data.

“The H20 is a potent accelerator of China’s frontier AI capabilities, not an outdated AI chip,” the letter said. “Designed specifically to work around export control thresholds, the H20 is optimized for inference, the process responsible for the dramatic capabilities gains made by the latest generation of frontier AI reasoning models. For inference tasks, the H20 outperforms even the H100, an AI chip this administration has restricted access to due to its advanced capabilities.”

The letter noted that U.S. and Chinese labs envision further investment in inference computing “will be critical to the next leap in frontier AI capabilities.”

Chinese labs have been bulk ordering H20 chips to develop even more advanced AI models.

The letter claims selling those chips to China will worsen the supply bottleneck in the United States, noting projected data center demand would require 90% of global chip supply through 2030 even without China getting them.

Also, the experts say these chips can be used to support China’s military, writing “we fully expect the H20 and the AI models it supports to be deployed by China’s People’s Liberation Army.”

And they warn it will weaken overall chip exports controls, writing “such a policy is likely to generally weaken export controls as an effective foreign policy tool for the United States. This policy reversal is likely to create confusion among both allies and competitors, and may even be interpreted as a weakening of U.S. resolve on other key issues in which trade and national security may be in tension with one another.”

Earlier this month, the government allowed the chip sales as part of trade discussions with China on rare earth elements. In May, the White House said sales of the chip to China would be restricted.

“The decision to ban H20 exports earlier this year was the right one,” the letter said. “We ask you to stand by that principle and continue blocking the sale of advanced AI chips to China as America works to maintain its technological edge. This is not a question of trade. It is a question of national security.”

Nvidia founder and CEO Jensen Huang met with Trump and other legislators earlier this month. Huang also traveled to Beijing to meet with industry and government officials.

“We want to keep having the Chinese use the American technology stack because they still rely upon it,” Lutnick said on CNBC on July 15.

In April, the U.S. Securities and Exchange Commission had told Nvidia it would need a license to sell the chips to China, which froze those sales as the H20 chips had been designed explicitly to sidestep earlier export controls on Beijing.

Huang said the company wants domestic job creation, including manufacturing.

Nvidia has market capitalization of $4.2 trillion, making it the world’s most valuable company, according to CompaniesMarketCap. At one time Apple and Microsoft topped the list.

The company’s stock price rose 1.87% Monday to a record-high $176.75 on Nasdaq. The company began trading in 1999.

Although EGFR TKIs have helped move the needle for the treatment of patients with EGFR-mutant advanced and early-stage non–small cell lung cancer (NSCLC) throughout the past 2 decades, there is a pressing unmet need for translating the disease-free survival (DFS) benefit seen with these agents into a more significant overall survival (OS) benefit in the early-stage setting, according to Roy S. Herbst, MD, PhD.¹

“EGFR TKIs have evolved. The first inhibitors were used in the clinic around 1996, and [efforts to target EGFR] mutations were established in 2004,” Herbst said during a presentation at the 26th Annual International Lung Cancer Congress. “Now, we use the new drugs in the adjuvant and the neoadjuvant setting. Of course, we’ll probably move to some of the newer combinations soon, it is just a matter of time.”

During the Congress, Herbst discussed the evolution of targeted agents and antibody-drug conjugates (ADCs) in the neoadjuvant and adjuvant settings, and two phase 3 studies designed to potentially bridge this gap in treatment outcomes for patients with early-stage disease.

Herbst is the deputy director and chief of Medical Oncology and Hematology, as well as the assistant dean of Translational Research at Yale Cancer Center and Smilow Cancer Hospital, in New Haven, Connecticut.

ADAURA Trial

Herbst began his presentation by sharing several phase 3 studies attempting to demonstrate both a DFS and OS benefit with EGFR TKIs in early-stage NSCLC. One such trial was the phase 3 ADAURA study (NCT02511106), in which adjuvant osimertinib (Tagrisso) demonstrated significant DFS and OS benefit compared with placebo in resected EGFR-mutant stage IB to IIIA NSCLC.² Data from the updated DFS analysis revealed a median DFS of 65.8 months (95% CI, 61.7-not calculable) and 28.1 months (95% CI, 22.1-35.0) in the osimertinib vs placebo arms, respectively (HR, 0.27; 95% CI, 0.21-0.34). Furthermore, the DFS outcomes translated into 5-year OS rates of 88% (95% CI, 83-91) and 78% (95% CI, 73-82) in these respective arms (HR, 0.49; 95% CI, 0.34-0.70; P < .001).

“This was a positive result, and [osimertinib] has become the standard of care in most countries,” Herbst said.

The molecular residual disease (MRD) analysis of ADAURA, which was presented at the 2024 ASCO Annual Meeting, showed that DFS and MRD event-free status were maintained for most patients on and after receiving osimertinib.³

Results from the study showed that the majority of patients—regardless of disease stage—were MRD undetected at baseline. However, detectable MRD at baseline was associated with poorer outcomes in patients who were treated with osimertinib vs placebo. Notably, patients treated with osimertinib were more likely to be DFS and MRD event-free compared with placebo. At 24 months, the DFS and MRD event-free rates were 91% (95% CI, 84-95) and 46% (95% CI, 36-55) in the osimertinib (n = 112) vs placebo (n = 108) arms, respectively. At 36 months, these rates were 86% (95% CI, 78-92) and 36% (95% CI, 27-45) in these respective arms (HR, 0.23; 95% CI, 0.15-0.36).

Overall, the analysis helped identify molecular recurrence before DFS events, which emphasized [the] potential [utility of MRD event-free status] in this setting, Herbst noted. These findings further indicated that tumor-informed MRD could be used as a potential biomarker of disease recurrence, as circulating tumor DNA is historically challenging to leverage in early-stage NSCLC in the adjuvant setting, he stated.

“MRD could be helpful. The median time to identify progression was 4.7 months earlier using MRD,” Herbst explained. “[Therefore], if we start to use [tumor-informed] MRD [analysis] in some of these studies, that might help us to figure out who gets treated early.”

ALINA Trial

Herbst then discussed the phase 3 ALINA trial, which assessed adjuvant alectinib (Alecensa) for the treatment of patients with resectable, ALK-positive NSCLC. Findings published in The New England Journal of Medicine showed that, among the patient population with stage II or IIIA disease, the median DFS was not reached (NR) in those treated with alectinib compared with 44.4 months (95% CI, 27.8-not evaluable [NE]) in the chemotherapy arm (HR, 0.24; 95% CI, 0.33-0.45; P < .001).⁴ Similarly, patients in the intention-to-treat population demonstrated a median DFS of NR and 41.3 months (95% CI, 28.5-NE) in the alectinib vs chemotherapy arms, respectively (HR, 0.24; 95% CI, 0.13-0.43; P < .001).

NeoADAURA Trial

Lastly, Herbst circled back to the phase 3 NeoADAURA trial (NCT04351555), which investigated osimertinib with or without chemotherapy compared with chemotherapy alone in the neoadjuvant setting for the treatment of patients with resectable EGFR-mutant NSCLC, findings from which were presented at the 2025 ASCO Annual Meeting. In this trial, the major pathologic response (MPR) rate was statistically significantly higher with osimertinib with or without chemotherapy compared with placebo plus chemotherapy.⁵ Specifically, the MPR rate was 26% (95% CI, 18%-34%) in the osimertinib plus chemotherapy arm (n = 121) and 25% (95% CI, 17%-34%) in the osimertinib monotherapy arm (n = 117) compared with only 2% (95% CI, 0%-6%) in the placebo plus chemotherapy arm (n = 120; odds ratio, 19.3; 99.9% CI, 1.7-217.4; P < .0001). Furthermore, 53% of patients with baseline N2 disease were down-staged at surgery in both the osimertinib plus chemotherapy (n = 47) and osimertinib monotherapy arms. In contrast, 21% of patients in the placebo plus chemotherapy arm were down-staged at surgery. Odds ratios were 4.8 (95% CI, 1.6-14.0) and 4.2 (95% CI, 1.4-12.1) in the osimertinib plus chemotherapy and osimertinib monotherapy arms vs placebo plus chemotherapy arm, respectively.

Following the December 2020 FDA approval of adjuvant osimertinib for the treatment of patients with EGFR-mutant NSCLC, the treatment paradigm in NSCLC has increasingly focused on bringing targeted therapies into earlier disease settings, Herbst emphasized, adding that he hopes to see this trend continue.

“[Isaiah J. Fidler, DVM, PhD, FAACR,] used to always say that it’s metastases that kill patients, and that’s to the point here. Using these targeted therapies in the adjuvant setting can really [help prevent] metastases to the brain, liver, and the bone,” Herbst concluded.

References

1. Herbst RS. Targeted agents and ADCs in early-stage NSCLC—what’s new? Presented at: 26th Annual International Lung Cancer Congress; July 25-26, 2025; Huntington Beach, CA.
2. Herbst RS, Wu YL, John T, et al. Adjuvant osimertinib for resected EGFR-mutated stage Ib-IIIa non-small-cell lung cancer: updated results from the phase III randomized ADAURA trial. J Clin Oncol. 2023;41(10):1830-1840. doi:10.1200/JCO.22.02186
3. John T, Grohe C, Goldman JW, et al. Molecular residual disease (MRD) analysis from the ADAURA trial of adjuvant (adj) osimertinib in patients (pts) with resected EGFR-mutated (EGFRm) stage IB-IIIA non-small cell lung cancer (NSCLC). J Clin Oncol. 2024;42(suppl 16):8005. doi:10.1200/JCO.2024.42.16_suppl.800
4. Wu YL, Dziadziuszko R, Ahn JS, et al. Alectinib in Resected ALK-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2024;390(14):1265-1276. doi:10.1056/NEJMoa2310532
5. He J, Tsuboi M, Weder W, et al. Neoadjuvant Osimertinib for Resectable EGFR-Mutated Non-Small Cell Lung Cancer. J Clin Oncol. Published online June 2, 2025. doi:10.1200/JCO-25-00883