Category: 3. Business

  • CrowdStrike Named the Only Leader & Outperformer in 2025 GigaOm SSPM Radar Report

    CrowdStrike Named the Only Leader & Outperformer in 2025 GigaOm SSPM Radar Report

    CrowdStrike recognized for delivering the most innovative and complete platform for SaaS security, earning the highest scores in Key Features and Business Criteria among all evaluated vendors

    AUSTIN, Texas – August 12, 2025 – CrowdStrike (NASDAQ: CRWD) today announced it is the only vendor named both a Leader and an Outperformer in the 2025 GigaOm Radar Report for SaaS Security Posture Management (SSPM). The report recognized CrowdStrike as the most innovative and complete Platform Play, with the highest scores among all vendors in Key Features and Business Criteria. CrowdStrike earned perfect 5/5 scores across critical evaluation areas, including SaaS Support, Policy Management, Third-Party Risk Assessment, Identity Threat Detection and Response, Enterprise Security Infrastructure Integration, Scalability, Cost, and Ecosystem.

    This recognition underscores the competitive advantage of CrowdStrike’s unified approach to SaaS security, securing every identity – human, non-human, and AI agent – to stop SaaS breaches and prevent cross-domain attacks. GigaOm highlighted that “CrowdStrike’s single-platform architecture is comprehensive, consolidating SSPM, SaaS DLP, cloud security, identity security, and endpoint protection into a single console, enabling automated, real-time policy responses to swiftly stop attacks.”

    Adversaries increasingly exploit trusted identities to infiltrate organizations undetected, making SaaS environments a top target. With hundreds of SaaS applications in use across enterprises, even minor misconfigurations or excessive permissions create entry points for infiltration and lateral movement. At the same time, the explosion of AI agents in SaaS environments is rapidly expanding the attack surface, with more identities holding persistent, high-risk privileges that adversaries can exploit across identity, endpoint, and cloud systems. To address this emerging risk, CrowdStrike recently expanded Falcon Shield support for OpenAI’s ChatGPT Enterprise Compliance API, enabling visibility and governance over autonomous GPT-based agents like Codex and custom GPTs.

    The AI-native CrowdStrike Falcon® platform delivers the unified protection organizations need to secure this modern threat landscape. CrowdStrike Falcon® Shield delivers complete SaaS Security Posture Management, protecting identities, configurations, and data across SaaS applications. Combined with Falcon® Identity Protection and Falcon® Cloud Security, CrowdStrike secures every human and non-human identity – from initial access to privilege escalation and lateral movement – across SaaS, cloud, and on-prem environments.

    CrowdStrike Falcon platform differentiators recognized by GigaOm include:

    • Complete SaaS Visibility: GigaOm emphasized that Falcon Shield discovers SaaS applications and provides “visibility into SaaS threats, including misconfigured apps, excessive permissions, identity compromise, and unauthorized data access,” with over 175 pre-built integrations. 
    • Automated Threat Response: GigaOm highlighted Falcon® Fusion, CrowdStrike’s no-code SOAR engine, for delivering “automated, real-time policy responses,” such as “disabling users or revoking OAuth app access” to contain threats before they escalate.
    • GenAI and Autonomous Agent Control: CrowdStrike provides comprehensive protection for GenAI, AI agents, and embedded AI tools in SaaS environments. GigaOm noted that CrowdStrike is enhancing these capabilities through Charlotte AI, with “GenAI tools that can monitor SaaS applications, enforce standards, manage AI settings to prevent data leakage, and identify shadow AI apps.”
    • Power of the Platform: GigaOm noted that CrowdStrike “delivers a comprehensive platform for those wishing to consolidate SSPM into a broader stack, including endpoint management, ITDR, and other SaaS-related security disciplines, all of which can be covered by the extensive Falcon platform.”


    “Modern attacks frequently start with adversaries exploiting fragmented identity controls across SaaS, cloud, and endpoint environments to gain access, escalate privileges, and move laterally, often without detection,” said Elia Zaitsev, chief technology officer at CrowdStrike. “SaaS has become one of the most exposed and least governed layers of the enterprise. Attempting to secure it in isolation leaves gaps adversaries can exploit. Organizations need a unified platform that correlates identity, configuration, and behavioral signals across security domains to deliver real-time protection. GigaOm’s recognition validates CrowdStrike’s leadership in delivering that platform purpose-built to protect every identity across the modern attack surface.”

    To learn more about the 2025 GigaOm Radar Report for SSPM, visit here and read our blog.

    About CrowdStrike

    CrowdStrike (NASDAQ: CRWD), a global cybersecurity leader, has redefined modern security with the world’s most advanced cloud-native platform for protecting critical areas of enterprise risk – endpoints and cloud workloads, identity and data.

    Powered by the CrowdStrike Security Cloud and world-class AI, the CrowdStrike Falcon® platform leverages real-time indicators of attack, threat intelligence, evolving adversary tradecraft and enriched telemetry from across the enterprise to deliver hyper-accurate detections, automated protection and remediation, elite threat hunting and prioritized observability of vulnerabilities.

    Purpose-built in the cloud with a single lightweight-agent architecture, the Falcon platform delivers rapid and scalable deployment, superior protection and performance, reduced complexity and immediate time-to-value.

    CrowdStrike: We stop breaches.

    Learn more: https://www.crowdstrike.com/

    Follow us: Blog | X | LinkedIn | Facebook | Instagram

    Start a free trial today: https://www.crowdstrike.com/free-trial-guide/

    © 2025 CrowdStrike, Inc. All rights reserved. CrowdStrike and CrowdStrike Falcon are marks owned by CrowdStrike, Inc. and are registered in the United States and other countries. CrowdStrike owns other trademarks and service marks and may use the brands of third parties to identify their products and services.

    Media Contact

    Jake Schuster

    CrowdStrike Corporate Communications

    press@crowdstrike.com


    Continue Reading

  • Elon Musk threatens Apple with lawsuit over OpenAI, sparking Sam Altman feud | Elon Musk

    Elon Musk threatens Apple with lawsuit over OpenAI, sparking Sam Altman feud | Elon Musk

    Elon Musk has threatened legal action against Apple on behalf of his artificial intelligence startup xAI, accusing the iPhone maker of favoring OpenAI and breaching antitrust regulations in managing the rankings in its App Store. The posts elicited snide responses from Sam Altman, the OpenAI CEO, and began a spat between the two former business partners on X.

    “Apple is behaving in a manner that makes it impossible for any AI company besides OpenAI to reach #1 in the App Store, which is an unequivocal antitrust violation. xAI will take immediate legal action,” Musk said in a post on X.

    In a post earlier that day, he wrote: “Hey @Apple App Store, why do you refuse to put either X or Grok in your ‘Must Have’ section when X is the #1 news app in the world and Grok is #5 among all apps? Are you playing politics?”

    OpenAI’s ChatGPT currently holds the top spot in the App Store’s “Top Free Apps” section in the US, while xAI’s Grok ranks fifth. Apple has a partnership with OpenAI that integrates ChatGPT into iPhones, iPads and Macs. Apple and xAI did not provide comment.

    Altman responded to Musk on X: “This is a remarkable claim given what I have heard alleged that Elon does to manipulate X to benefit himself and his own companies and harm his competitors and people he doesn’t like.” Musk has bent X’s algorithmic recommendations to favor his own tweets, according to multiple reports.

    Altman and Musk founded OpenAI together in 2015, but Musk left the startup and rescinded funding in 2018 after proposing to take it over, a petition other executives rebuffed. Musk has since sued the company twice over its planned transition to a for-profit enterprise, alleging “deceit of Shakespearean proportions”. Altman has cast Musk as a bitter and petty ex-partner who was jealous of the company’s success after departing.

    Musk replied to Altman’s tweet: “You got 3M views on your bullshit post, you liar, far more than I’ve received on many of mine, despite me having 50 times your follower count!”

    Altman replied to Musk multiple times, first calling his lack of views a “skill issue”, then “or bots”, and then offered a legal question of his own: “Will you sign an affidavit that you have never directed changes to the X algorithm in a way that has hurt your competitors or helped your own companies? i will apologize if so.”

    Users on X – through the community notes feature – have pointed out that a few apps besides OpenAI have taken the top spot on the App Store this year.

    Chinese AI app DeepSeek reached the No 1 spot on the platform in January, while in July, Perplexity took first place in India’s App Store – both occurring after the OpenAI and Apple partnership struck last year.

    One user asked X’s native AI, Grok, who was right in the feud. The chatbot replied: “Based on verified evidence, Sam Altman is right.”

    skip past newsletter promotion

    Musk’s comments come as regulators and rivals intensify scrutiny of Apple’s control over its App Store.

    Earlier this year, Apple was ordered to pay a fine of €500m ($581.15m) by the EU antitrust enforcer, which said the company’s restrictions prevented developers from steering users outside the App Store.

    The US Department of Justice filed an antitrust lawsuit against Apple in early 2024, accusing the iPhone maker of creating and maintaining “broad, sustained, and illegal” smartphone monopoly.

    Continue Reading

  • Real-World Outcomes Support Use of First-Line Palbociclib Plus ET in HR+/HER2– Advanced Breast Cancer

    Real-World Outcomes Support Use of First-Line Palbociclib Plus ET in HR+/HER2– Advanced Breast Cancer

    Image Credit: © Axel Kock – stock.adobe.com

    Findings from a real-world, retrospective study conducted in Europe showed that outcomes for patients with advanced hormone receptor (HR)–positive/HER2-negative advanced breast cancer treated with first-line palbociclib (Ibrance) plus endocrine therapy (ET) support the use of this regimen as a frontline treatment option.1

    Data published in Breast Cancer Research and Treatment demonstrated that evaluable patients treated in the United Kingdom (UK; n = 481) experienced an overall response rate (ORR) of 34.9% and a clinical benefit rate (CBR) of 80.7%. In patients from Spain (n = 251), the ORR and CBR were 43.8% and 86.1%, respectively. The respective ORR and CBR were 16.9% and 79.0% in patients from Germany (n = 124).

    In the UK cohort, the median progression-free survival (PFS) and overall survival (OS) were 33.9 months (95% CI, 28.1-41.1) and 51.3 months (95% CI, 46.6-not evaluable [NE]), respectively. The median PFS was 28.1 months (95% CI, 24.6-35.1) in patients from Spain, who also experienced a median OS that was NE (95% CI, 47.5-NE). In the German cohort, the median PFS was 48.1 months (95% CI, 34.1-NE), and the median OS was 65.2 months (95% CI, 65.2-NE).

    In the United States, palbociclib plus aromatase inhibitor is approved by the FDA as initial endocrine-based therapy for patients with HR-positive/HER2-negative advanced or metastatic breast cancer, based on data from the phase 3 PALOMA-2 trial (NCT01740427).2 Findings supporting the approval showed that patients who received palbociclib plus letrozole (n = 444) experienced an ORR of 55.3% (95% CI, 49.9%-60.7%), a median PFS of 24.8 months (95% CI, 22.1-NE), and a median OS of 53.8 months (95% CI, 49.8-59.2).

    “This [retrospective] study adds to a growing body of real-world evidence supporting the clinical effectiveness of palbociclib and other CDK4/6 inhibitor combination therapies for [patients] with HR-positive/HER2-negative advanced breast cancer,” lead study author Olga Oikonomidou, BSc, MSc, MRes, MD, PhD, FRCP, and colleagues wrote in a publication of the data.1

    Oikonomidou is a consultant medical oncologist, a senior clinical lecturer in Breast Cancer Medicine, and leader of the Breast Cancer Translational Research Group at the University of Edinburgh in Scotland.

    “It is important to supplement findings from randomized clinical trials with real-world evidence from heterogeneous populations of patients in routine clinical practice who may be ineligible or underrepresented in clinical trials,” Oikonomidou and colleagues added.

    How Real-World Palbociclib Data Were Gathered

    To conduct the retrospective study, investigators identified patients from 52 treatment centers across the UK, Spain, and Germany. The study included patients at least 18 years of age with histologically or cytologically confirmed HR-positive/HER2-negative unresectable, advanced, or metastatic breast cancer who started first-line treatment with palbociclib plus an AI during the study index period from September 1, 2016, to July 31, 2020.

    Investigators excluded patients who participated in a clinical trial evaluating a treatment for advanced, irrespective if participation occurred before or after first-line palbociclib. Patients were also excluded if they received prior treatment with any CDK4/6 inhibitor in the early-stage setting or received any CDK4/6 inhibitor–based regimen after first-line palbociclib.

    The median age at diagnosis was 63.4 years (standard deviation [SD], 12.2) in the UK cohort, 61.9 years (SD, 12.8) in the Spain cohort, and 66.6 years (SD, 12.8) in the Germany cohort. Most patients were female (UK, 100%; Spain, 98.8%; Germany, 99.2%) and White (75.9%; 92.8%; 87.1%). The median duration of follow-up was 33.7 months in the UK group, 32.7 months in the Spain group, and 32.6 months in the Germany group.

    The majority of patients in the UK cohort (62.0%) and Spain cohort (55.0%) were initially diagnosed with early-stage breast cancer, whereas most patients in the Germany cohort had de novo advanced disease (49.2%). Most patients in all 3 groups had a disease-free interval of more than 12 months (UK, 59.1%; Spain, 68.8%; Germany, 52.5%) and had 1 distant metastatic site (43.2%; 52.5%; 52.5%).

    Across the 3 cohorts, patients had approximately 2 comorbidities at baseline, with the most common comprising hypertension (22.9%-45.2%), diabetes without end-organ damage (5.6%-12.1%), and depression (8.1%-11.6%).

    Study Limitations

    Oikonomidou and colleagues explained that data provided for this study were from centers willing to participate, meaning they may not be generalizable to other sites in different countries. They also noted that the study lacked a comparator arm, and sample sizes were limited for all 3 countries.

    Additionally, since the study did not include patients who received subsequent CDK4/6 inhibitor–based regimens in the second or third line of therapy, study authors explained that these results may not be representative of this full patient population.

    References

    1. Oikonomidou O, Beresford MJ, Galve-Calvo E, et al. Real-world clinical outcomes associated with first-line palbociclib and aromatase inhibitor therapy among patients with HR+/HER2- advanced breast cancer in Europe. Breast Cancer Res Treat. Published online August 6, 2025. doi:10.1007/s10549-025-07707-5
    2. Ibrance. Prescribing information. Updated April 2025. Accessed August 12, 2025. https://labeling.pfizer.com/ShowLabeling.aspx?id=2191#section-12

    Continue Reading

  • Oil Dips in Thin Summer Trading Ahead of Trump-Putin Meeting

    Oil Dips in Thin Summer Trading Ahead of Trump-Putin Meeting

    Oil inched higher as investors weighed President Donald Trump’s deferral of lofty US tariffs on China Photographer: Angel Navarrete/Bloomberg

    Oil slipped as investors weighed US President Donald Trump’s deferral of lofty tariffs on China against possible outcomes from his planned meeting with Russia’s Vladimir Putin.

    West Texas Intermediate dropped near $63 a barrel in muted summer trading, near last week’s two-month low. Trump extended for another 90 days a truce that was set to expire Tuesday. US inflation data, meanwhile, bolstered speculation the Federal Reserve will soon be able to cut interest rates.

    Most Read from Bloomberg

    Absent any major drivers, traders are looking to the summit between Trump and Putin later this week for signs sanctions on the major oil producer will be eased, although the US president on Monday downplayed expectations for a deal to end the war in Ukraine.

    The aggregate trading volume of global benchmark Brent is well below its daily average — suggesting traders are exercising caution as they seek further insight into the oil market’s outlook. Prices are down by more than 8% this month after trade and geopolitical tensions eased, while many analysts anticipate a supply glut later this year.

    Meanwhile, the US government now expects domestic oil production to fall next year, reversing years of output growth. The EIA also estimated the supply glut would increase to 1.7 million barrels a day in 2026. Looking ahead, the International Energy Agency will release its report on Wednesday.

    Most Read from Bloomberg Businessweek

    ©2025 Bloomberg L.P.

    Continue Reading

  • Neutrophil-targeted drug secures first FDA approval for inflammatory lung disease

    You have full access to this article via your institution.

    The FDA has approved Insmed’s brensocatib (Brinsupri)— an oral small-molecule inhibitor of dipeptidyl peptidase 1 (DPP1) — for non-cystic fibrosis bronchiectasis. It is the first drug specifically approved to treat this inflammatory lung disease, which affects an estimated 350,000–500,000 people in the USA.

    “The unmet need is massive,” says James Chalmers, a respiratory clinician scientist at the University of Dundee who led the clinical trials of brensocatib.

    Insmed’s first-in-class brensocatib could command annual sales of over US$4 billion by 2031, show consensus sales estimates on the Cortellis database. Insmed bought brensocatib from AstraZeneca in 2016 for $160 million.

    Bronchiectasis is a chronic, progressive immune-mediated disease that causes excessive mucus production, persistent cough and widening of the airways — impairing lung function. Recurrent exacerbations lead to hospitalization in many patients. Until now, treatment involved physical therapy to promote mucus clearance and antibiotics to tackle associated respiratory infection.

    Brensocatib is the first drug to target neutrophils, innate immune cells that home to sites of infection where they engulf pathogens, produce cytokines to recruit other immune cells and release antimicrobial peptides called neutrophil serine proteases (NSPs). Over-activation of neutrophils and excessive NSP production drives bronchiectasis as well as other inflammatory diseases.

    The DPP1 protease activates NSPs during neutrophil maturation in the bone marrow. By inhibiting DPP1, brensocatib disarms NSPs while sparing other effector functions of neutrophils that are needed to fight infections.

    “Brensocatib now gives you the opportunity to address the underlying disease,” says Martina Flammer, Chief Medical Officer at Insmed. “It is a game-changer.”

    In a pivotal trial in 1,721 patients who had experienced at least two exacerbations in the past year, daily brensocatib (10 mg or 25 mg) for 1 year met the primary end point, cutting the annualized rate of exacerbations by 20% versus placebo. In the high-dose group, the rate of decline in lung function was slowed to a level in line with normal ageing. Longer studies are needed to test whether the benefit to lung function persists. The drug was generally safe and well-tolerated, with no effect on the rate of infection.

    Over 20 years ago, researchers showed that DPP1-knockout mice were protected against inflammatory arthritis. But a rare genetic condition in humans who lack DPP1 dampened industry interest in the target, as these individuals have substantial abnormalities of the skin and teeth. GSK’s irreversible DPP1 inhibitor GSK2793660 also caused skin abnormalities in a phase II bronchiectasis trial and was discontinued.

    Brensocatib is a reversible covalent inhibitor that seems to have hit a sweet spot in DPP1 inhibition. Brensocatib was associated with hyperkeratosis, a thickening of the skin’s outer layer, in some patients in its phase III trial, but this was mostly mild and only led to treatment discontinuation in one patient.

    A handful of other DPP1 inhibitors are in development, including two candidates in phase III trials for bronchiectasis. Drug developers are also looking at other inflammatory indications with strong neutrophilic components for these agents (Table 1).

    “[Brensocatib is] opening up this pathway for potentially other diseases,” says Kevin Mange, Chief Development Officer at Insmed. “I think you’ll see more coming.”

    AstraZeneca retains the rights to brensocatib for asthma and chronic obstructive pulmonary disease (COPD). The company was testing brensocatib in COPD, but removed the drug from its pipeline in 2023. They declined to comment on development plans.

    Continue Reading

  • Trading platform eToro's CEO highlights retail investor surge as profit beats estimates – Reuters

    1. Trading platform eToro’s CEO highlights retail investor surge as profit beats estimates  Reuters
    2. EToro Posts 26% Jump In Q2 Revenue As Assets Climbs Past $17 Billion  FinanceFeeds
    3. eToro’s Resilient ECC Performance and Growth Prospects Amid Crypto Challenges: A Buy Recommendation by James Yaro  TipRanks
    4. EToro Posts Strong Results Thanks to Retail Trading Surge for Stocks and Crypto  Barron’s
    5. eToro Q3 Net Income Hits $30.2 Million Amid Market Volatility  AInvest

    Continue Reading

  • Expedia Group Second Quarter 2025 Earnings: Revenues Beat Expectations, EPS Lags – Yahoo Finance

    Expedia Group Second Quarter 2025 Earnings: Revenues Beat Expectations, EPS Lags – Yahoo Finance

    1. Expedia Group Second Quarter 2025 Earnings: Revenues Beat Expectations, EPS Lags  Yahoo Finance
    2. Expedia shares soar on upbeat forecast, US travel rebound  Reuters
    3. EXPE Q2 Deep Dive: B2B and International Growth Offset U.S. Travel Softness  FinancialContent
    4. Expedia Posted Strong Earnings. What Wall Street Is Saying About the Stock.  Barron’s
    5. Expedia Group (EXPE) Is Up 9.7% After Raising Revenue Guidance and Affirming Dividend – What’s Changed  simplywall.st

    Continue Reading

  • Perplexity AI makes unsolicited $34.5bn bid to buy Google Chrome | Technology News

    Perplexity AI makes unsolicited $34.5bn bid to buy Google Chrome | Technology News

    This is the second major offer the AI startup has made this year to buy a major asset. In January, it offered to buy TikTok.

    Perplexity AI said it has made a $34.5bn unsolicited all-cash offer for Alphabet’s Google Chrome browser.

    The deal, if Alphabet agreed to it, would also require financing above the startup’s most recently reported valuation of $18bn.

    The nearly three-year-old startup’s purchase of Chrome, if approved, would give the company access to its more than three billion users as regulatory pressure weighs on Google’s control over the tech industry.

    Perplexity did not disclose on Tuesday how it plans to fund the offer, but has raised $1bn in funding from investors including SoftBank and the semiconductor chip giant Nvidia.

    Several funds have said they would finance the deal in full if Alphabet accepts, the Reuters news agency reported citing unnamed sources familiar with the matter.

    Alphabet has not offered to sell Chrome and has planned to appeal a United States court ruling that said Google held an unlawful monopoly over the online search marketplace. The US Department of Justice has said that divestiture of Chrome would help remedy that case. A federal judge is expected to rule on remedies for the case later this month.

    Web browsers as vital gateways

    As a new generation of users turns to chatbots such as ChatGPT and Perplexity for answers, web browsers are regaining prominence as vital gateways to search traffic and prized user data, making them central to Big Tech’s AI ambitions.

    Perplexity already has an AI browser, Comet, that can perform certain tasks on a user’s behalf. Buying Chrome would allow it to tap the browser’s more than three billion users, giving it the heft to better compete with bigger rivals such as OpenAI. The ChatGPT parent is also working on its own AI browser.

    Perplexity, run by CEO Aravind Srinivas, has said it will keep the browser’s code open source and make no changes to the default search engine, according to Reuters.

    The San Francisco-based startup is far from the only company to express interest in Google Chrome. ChatGPT owner OpenAI has also expressed interest, as has Yahoo and New York-based private equity firm Apollo Global Management.

    It is not the first eye-catching bid from the AI startup this year. In January, Perplexity AI offered to buy TikTok after regulators called for the Chinese-owned app to be sold to a US company. The White House has delayed the ban several times. The most recent delay was announced in late June.

    Neither Google nor Perplexity immediately responded to Al Jazeera’s request for comment.

    On Wall Street, Alphabet’s share price surged up 1.4 percent since the market opened. Potential funder Nvidia is relatively flat, only up about 0.1 percent. However, SoftBank is surging up more than 6.9 percent as of 1pm in New York (17:00 GMT). Perplexity is not a publicly traded company.

    Continue Reading

  • FDA grants priority review for new oral gonorrhea antibiotic – CIDRAP

    FDA grants priority review for new oral gonorrhea antibiotic – CIDRAP

    1. FDA grants priority review for new oral gonorrhea antibiotic  CIDRAP
    2. FDA Grants Priority Review for Gepotidacin for Gonorrhea  Contagion Live
    3. GSK opens higher after priority review for new gonorrhoea pill  Proactive financial news
    4. GSK’s Gepotidacin Gains Priority Review for Gonorrhoea Treatment  TipRanks
    5. GSK’s oral antibiotic for gonorrhoea set for FDA review  Yahoo Finance

    Continue Reading

  • Relacorilant Plus Nab-Paclitaxel May Serve As New Standard of Care in Platinum-Resistant Ovarian Cancer

    Relacorilant Plus Nab-Paclitaxel May Serve As New Standard of Care in Platinum-Resistant Ovarian Cancer

    Domenica Lorusso, MD, PhD

    The addition of nab-paclitaxel to relacorilant (Abraxane) further improved progression-free survival (PFS) vs nab-paclitaxel alone in patients with platinum-resistant ovarian cancer, meeting the primary end point of the phase 3 ROSELLA trial (NCT05257408) and demonstrating the potential for this combination to improve upon the current standard of care (SOC), according to Domenica Lorusso, MD, PhD.1

    Data from the study, which were previously presented at both the 2025 ASCO Annual Meeting and the 2025 ESMO Gynecological Cancers Congress, revealed that the median PFS in the overall population was 6.54 months (95% CI, 5.55-7.43) and 5.52 months (95% CI, 3.94-5.88) with relacorilant plus nab-paclitaxel (n = 188) vs nab-paclitaxel (n = 193), respectively (HR, 0.70; 95% CI, 0.54-0.91; P = .0076). At 6 months, the respective PFS rates were 52% vs 42%. At 12 months, respective PFS rates were 25% vs 13%.

    “More than 60% of these patients had [previously] received PARP inhibitors,” Lorusso explained during an interview with OncLive®. “We know that these patients are very difficult to treat, as [many] of these patients are [not only] resistant to PARP [inhibitors], but are also resistant to platinum[-based chemotherapy]. It’s a huge unmet clinical need to identify treatments that are effective for patients progressing during PARP [inhibitor therapy].”

    In the interview, Lorusso discussed the background of the ROSELLA trial, efficacy and safety data from the study, potential clinical implications, and next steps for evaluating the relacorilant-based regimen.

    Lorusso is the director of the Gynecological Oncology Unit at Humanitas Hospital San Pio X in Milan, as well as a full professor of Obstetrics and Gynecology at Humanitas University in Rozzano, Italy.

    OncLive: What was the rationale and design of the ROSELLA trial?

    Lorusso: We have discovered that glucocorticoid receptor signaling can reduce sensitivity to chemotherapy. Preclinical and early clinical data suggest that ovarian cancer expresses the glucocorticoid receptor, which is a marker of poor prognosis. The data suggest that when cortisol activates the glucocorticoid receptor, it can induce the transcription of anti-apoptotic genes that are involved in epithelial-mesenchymal transition and resistance to chemotherapy. This is why targeting this receptor with relacorilant, a selective glucocorticoid receptor antagonist, is interesting. We have phase 2 data suggesting that when we combine intermittent relacorilant with nab-paclitaxel, we can increase PFS and overall survival [OS] in platinum-resistant ovarian cancer. We chose nab-paclitaxel instead of weekly paclitaxel, which is more commonly used in ovarian cancer because nab-paclitaxel does not require corticosteroid premedication. Because relacorilant is a glucocorticoid receptor antagonist, we only combine drugs that do not require a glucocorticoid receptor.

    The ROSELLA trial is a randomized phase 3 trial comparing nab-paclitaxel with relacorilant plus nab-paclitaxel in platinum-resistant and refractory patients, [which we defined as] patients [whose disease] progressed between 1 and 3 months [after] prior platinum[-based therapy]. We are analyzing the data of the efficacy of the drug in patients progressing during PARP [inhibitor therapy]. These patients could not have received more than 3 prior lines of therapy, and prior bevacizumab [Avastin] was required. The trial has 2 primary end points: PFS, as evaluated according to RECIST 1.1 criteria by a blinded independent central review, and OS.

    What were the key efficacy data?

    The trial met its primary [PFS] end point, [with] a significant increase in PFS reported in patients treated with relacorilant/nab-paclitaxel. The median PFS was 5.5 months with nab-paclitaxel vs 6.5 months with relacorilant plus nab-paclitaxel. The HR was 0.70, suggesting a 30% reduction in the risk of [disease] progression [or death]. [Data from] the interim analysis for OS [showed that] the median OS increased from 11.5 months in the nab-paclitaxel arm to 15.97 months in the relacorilant plus nab-paclitaxel arm, with a HR of 0.69. [These data are] not yet mature; we have to wait for the final OS data.

    Interestingly, there was a slight improvement in overall response rate [ORR], [with a] 7% improvement. [The ORR was] 30.1% with nab-paclitaxel and 36.9% with relacorilant plus nab-paclitaxel. [Regarding] the clinical benefit rate, there was a 12% [improvement with the relacorilant combination].

    What was the safety profile of relacorilant in this study?

    The safety profile of the drug was manageable. The most frequently reported adverse effects [AEs] were neutropenia, anemia, and fatigue in patients treated with the relacorilant plus nab-paclitaxel arm. Hematologic AEs included neutropenia and anemia. [Interestingly], the duration of exposure was different in patients receiving nab-paclitaxel or nab-paclitaxel plus relacorilant. When we adjusted the hematological toxicity of neutropenia and anemia for the duration of exposure, the incidence and rates of neutropenia and anemia were very comparable between the 2 treatment arms. We can conclude that the toxicity profile is mainly hematological, but manageable.

    What are the potential clinical implications of these findings?

    [Nab-paclitaxel plus relacorilant] can be easily considered a new SOC for our patient with platinum-resistant and refractory ovarian cancer. [What was interesting about] the trial is that the comparator arm was nab-paclitaxel. According to the indirect trial comparison data we have, [this is] as effective as weekly paclitaxel, [which] we consider [to be] the most effective drug in the platinum-resistant setting. What we demonstrate with the ROSELLA trial is that when we add relacorilant to the best drug in the platinum-resistant setting, we further increase PFS.

    What future investigations are planned based on this research?

    We are now running the BELLA trial [NCT06906341], which is a single-arm phase 2 trial combining nab-paclitaxel and relacorilant with bevacizumab. In the ROSELLA trial, all the patients should have received prior bevacizumab; therefore, we only have the data of nab-paclitaxel plus relacorilant. In the BELLA trial, we have both cohorts: the patients who have previously received bevacizumab, and patients who have not previously received bevacizumab. All these patients are treated with the triplet regimen of nab-paclitaxel, relacorilant, and bevacizumab.

    Reference

    Lorusso D, Gladieff L, Gilbert L, et al. Phase III results of relacorilant + nab-paclitaxel vs nab-paclitaxel in platinum-resistant ovarian cancer (PROC) (ROSELLA, GOG-3073, ENGOT-ov72): secondary endpoints. Ann Oncol. 2025;10(suppl 5):105332. doi:10.1016/j.esmoop.2025.105332

    Continue Reading