– Additional Phase 3 PURPOSE data reinforce the safety profile of twice-yearly Yeztugo® as an effective HIV prevention option across diverse populations –
– New data show higher treatment satisfaction after switching from IM CAB+RPV to Biktarvy® –
– New research reaffirms Veklury® in high-risk COVID-19 populations and obeldesivir in emerging pathogens –
Source : Gilead Sciences, Inc.
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When it comes to Mets and Yankees caps, it’s not just about baseball. Don’t get me wrong, it’s definitely, like, a lot about baseball. The crosstown New York rivals have one of the more heated relationships in American sports, with the…
The combination of zanzalintinib (XL092) and atezolizumab (Tecentriq) improved overall survival (OS) compared with regorafenib (Stivarga) in patients with previously treated metastatic colorectal cancer (CRC), according to findings from the phase 3 STELLAR-303 trial (NCT05425940) presented at the
Across the intention-to-treat (ITT) population, data showed a median OS of 10.9 months with the zanzalintinib combination vs 9.4 months with regorafenib (HR, 0.80; 95% CI, 0.69-0.93; P = .0045). An interim analysis of findings in a subset of patients without liver metastases demonstrated a median OS of 15.9 months vs 12.7 months in each respective arm (stratified HR, 0.79; 95% CI, 0.61-1.03; P = .087).
Investigators noted an OS improvement with zanzalintinib/atezolizumab vs regorafenib across most key subgroups, which included patients from Asia (HR, 0.77; 95% CI, 0.59-1.00) and the rest of the world (HR, 0.82; 95% CI, 0.68-0.99), as well as those with RAS wild-type (HR, 0.79; 95% CI, 0.61-1.01) and RAS-mutated disease (HR, 0.80; 95% CI, 0.66-0.98). Additionally, the experimental combination improved OS for patients with (HR, 0.78; 95% CI, 0.65-0.94) and without liver metastases (HR, 0.77; 95% CI, 0.59-1.01); this benefit extended to those with (HR, 0.80; 95% CI, 0.68-0.95) and without prior anti-VEGF antibody therapy (HR, 0.80; 95% CI, 0.56-1.15).
The median progression-free survival (PFS) across the ITT population was 3.7 months with zanzalintinib/atezolizumab and 2.0 months with regorafenib; statistical significance for PFS could not be claimed at the time of analysis per prespecified hierarchical testing strategy (HR, 0.68; 95% CI, 0.59-0.79). The experimental combination generally conferred PFS improvements across patient subgroups.
Data showed an objective response rate (ORR) of 4% (95% CI, 2%-6%) in the zanzalintinib/atezolizumab arm, which consisted entirely of partial responses (PRs). Additionally, the ORR was 1% (95% CI, 0%-3%) in the regorafenib arm, which consisted entirely of PRs. The disease control rate (DCR) in the experimental and control arms was 54% (95% CI, 49%-58%) vs 41% (95% CI, 36%-45%), respectively.
“STELLAR-303 is the first phase 3 trial to show improved OS with an immune checkpoint inhibitor [ICI]–based combination in metastatic CRC that is not microsatellite instability–high [MSI-H] or mismatch repair deficient [dMMR]. The combination significantly prolonged OS compared to regorafenib in patients with previously treated metastatic CRC,” presenting author Anwaar Saeed, MD, a professor in the Department of Medicine of the Division of Hematology and Oncology at the University of Pittsburgh Medical Center and UPMC Hillman Cancer Center, stated in the presentation.1 “The combination of zanzalintinib and atezolizumab represents a potential novel chemotherapy-free for heavily pretreated [patients with] metastatic CRC in need of more improved therapy. The trial continues to the planned final OS in the subset of patients without liver metastases.”
In the open-label phase 3 STELLAR-303 trial, 901 patients with metastatic CRC documented to not have MSI-H or dMMR status were randomly assigned 1:1 to receive zanzalintinib at 100 mg orally each day plus atezolizumab at 1200 mg intravenously every 3 weeks (n = 451) or regorafenib at 160 mg orally once day on days 1 to 21 of each 28-day cycle (n = 450).
The trial’s dual primary end points were OS in the ITT population and among patients without liver metastases. Key secondary end points included PFS, ORR, and safety.
Patients 18 years and older with metastatic disease that had radiographically progressed on, was refractory to, or showed intolerance to prior standard-of-care treatment including fluoropyrimidine plus irinotecan and oxaliplatin with or without an anti-VEGF antibody, an anti-EGFR antibody, and a BRAF inhibitor were eligible for enrollment on the trial. Investigators stratified patients based on geographic region, RAS mutation status, and presence of liver metastases.
The median age was 60 years (range, 29-84) in the zanzalintinib/atezolizumab arm and 60 years (range, 29-85) in the regorafenib arm, with most patients from each being male (58% vs 60%), White (55% vs 53%), and from regions outside of Asia (65% vs 65%). Most patients from each respective arm had an ECOG performance status of 1 (53% vs 55%), a presence of liver metastases (59% vs 56%), BRAF wild-type status (75% vs 78%), and RAS-mutated disease (59% vs 60%). Nearly all patients across both arms received prior treatment with fluoropyrimidine plus irinotecan and oxaliplatin (>99% vs 100%).
The median time from random assignment to first subsequent line of anticancer therapy was 4.5 months (range, 0.2-20.4) in the zanzalintinib/atezolizumab arm and 3.7 months (range, 0.1-17.6) in the regorafenib arm; 44% and 42% of patients in each arm received subsequent treatment. Most patients in each respective arm received subsequent therapy with TAS-102 (27% vs 25%), bevacizumab (Avastin; 20% vs 20%), and TAS-102 in combination with bevacizumab (16% vs 16%).
Any-grade treatment-related adverse effects (TRAEs) occurred in 95% of the zanzalintinib/atezolizumab arm and 92% of the regorafenib arm; 57% and 42% from each experienced serious AEs, and 26% and 10% had serious TRAEs. Overall, 18% and 15% of patients in each arm had AEs resulting in treatment discontinuation, with 61% vs 40% requiring dose reduction of zanzalintinib and regorafenib, respectively, due to toxicity. Investigators noted treatment-related deaths due to intestinal perforation (n = 2) with zanzalintinib, pneumonitis (n = 1) and renal failure (n = 1) with atezolizumab, altered state of consciousness (n = 1) with zanzalintinib plus atezolizumab, and jejunal perforation (n = 1) with regorafenib.
In the zanzalintinib/atezolizumab and regorafenib arms, respectively, the most common AEs included diarrhea (50% vs 24%), hypertension (34% vs 26%), fatigue (33% vs 20%), nausea (31% vs 13%), and decreased appetite (30% vs 20%).
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Stocks rallied on Monday to the cusp of their records.
The Standard & Poor’s 500 climbed 1.1% and pulled within 0.3% of its all-time high set this month. The Dow Jones Industrial Average jumped 515 points, or 1.1%, and the Nasdaq composite gained 1.4%.
Apple led the way and rose 3.9% amid optimism about demand for its latest iPhone design. It was the strongest force lifting the S&P 500 and set its own record high.
Cleveland-Cliffs jumped 21.5% after the steel company’s chief executive, Lourenco Goncalves, said it would provide details soon about a potential deal with a major global steel producer that could mean bigger profits. He also said his company has potentially found signs of rare earths at sites in Michigan and Minnesota.
Such materials have grabbed the global spotlight after China recently put curbs on the export of its own rare earths, a move that President Trump characterized as hostile. Trump’s ensuing threat of higher tariffs triggered big swings for Wall Street, but the concerns eased a bit after he said such high tax rates on Chinese imports are unsustainable.
Another source of worry for Wall Street, from the banking industry, also appears to be easing. Stocks of smaller and midsize banks climbed Monday, recovering some of their losses after a couple raised alarm bells last week by warning about potentially bad loans they’ve made.
Zions Bancorp. gained 4.7% Monday after its 5.1% drop last week, when it said it had found “apparent misrepresentations and contractual defaults” related to a couple of borrowers.
Amazon’s stock held up despite a widespread outage of its cloud computing service that caused disruption for internet users around the world Monday. Amazon’s stock rose 1.6%.
All told, the S&P 500 added 71.12 points to 6,735.13. The Dow Jones Industrial Average climbed 515.97 to 46,706.58, and the Nasdaq composite gained 310.57 to 22,990.54.
This week features a raft of big names reporting their latest quarterly results, including Coca-Cola on Tuesday, Tesla on Wednesday and Procter & Gamble on Friday.
The pressure is on companies broadly to show that their profits are growing after a torrid run of 35% for the S&P 500 from a low in April. Delivering bigger profits is one of the easiest ways for companies to quiet criticism that stock prices have gone too high. The other is for stock prices to fall.
Corporate profit reports have also taken on more importance because they offer windows into the strength of the U.S. economy when the federal government’s shutdown has delayed important economic updates.
That’s making the job of the Federal Reserve more difficult, as it tries to decide whether high inflation or the slowing job market is the bigger issue for the economy. Fed officials have indicated they’re likely to cut rates several more times in order to give the economy a boost. But that could be a mistake if inflation worsens, because low interest rates can push it even higher.
On Friday, the U.S. government will issue an update for inflation during September. The report was supposed to arrive earlier in month, and the Social Security Administration needs the numbers to calculate cost-of-living adjustments for beneficiaries. But the government also said, “No other releases will be rescheduled or produced until the resumption of regular government services.”
In the bond market, Treasury yields held relatively steady. The yield on the 10-year Treasury eased to 3.98% from 4.02% late Friday.
In stock markets abroad, indexes rose across much of Europe and Asia.
Japan’s Nikkei 225 jumped 3.4%, after its governing Liberal Democrats found a new coalition partner, securing support for its leader Sanae Takaichi to become the country’s prime minister. Investors expect Takaichi, who would also be Japan’s first female prime minister, to push for low interest rates, higher government spending and other policies that could help the market.
Indexes rose 2.4% in Hong Kong and 0.6% in Shanghai after China reported its economy grew at a 4.8% annual pace in the last quarter, supported by relatively strong exports as companies increased shipments to markets other than the U.S.
Still, it was the slowest pace in a year. The world’s second-largest economy is still struggling to emerge from a prolonged downturn in its property market and to encourage consumers and businesses to spend more.
Choe writes for the Associated Press.
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