It’s been 40 years to the day since the Nintendo Entertainment System made its US debut, and to celebrate, gaming accessory maker 8BitDo has unveiled a line of NES-themed products. The includes a limited edition version of the company’s that…
Pembrolizumab (Keytruda) in combination with weekly paclitaxel, with or without bevacizumab (Avastin), statistically significantly improved progression-free survival (PFS) regardless of PD-L1 status and overall survival (OS) in PD-L1–expressing tumors in patients with platinum-resistant recurrent ovarian cancer (PRROC). These findings came from the phase 3 ENGOT-ov65/KEYNOTE-B96 trial (NCT05116189) and were shared at the
The analysis was broken down between the population of patients with a combined positive score (CPS) of 1 or higher and the intention-to-treat population. Furthermore, data were broken down between interim analysis 1 (IA1), which had a data cutoff date of April 3, 2024, and interim analysis 2 (IA2), which had a data cutoff date of May 5, 2025.
At IA1, the median PFS was 8.3 months (95% CI, 7.0-9.4) in the pembrolizumab arm compared with 7.2 months (95% CI, 6.2-8.1) in the placebo arm, with 12-month PFS rates of 35.2% (95% CI, 28.8%-41.7%) vs 22.6% (95% CI, 17.0%-28.7%), respectively (HR, 0.72; 95% CI, 0.58-0.89; P = .0014).
At IA2, the median PFS was 8.3 months in the pembrolizumab arm compared with 7.2 months in the placebo arm (HR, 0.75; 95% CI, 0.61-0.91); the 12-month PFS rates were 35.9% vs 23.9%, respectively, and the 18-month rates were 18.7% vs 10.5%.
The median OS was 18.2 months (95% CI, 15.3-21.0) in the pembrolizumab arm compared with 14.0 months (95% CI, 12.5-16.1) in the placebo arm, with 12-month OS rates of 69.1% vs 59.3%, and 18-month OS rates of 51.5% vs 38.9%, respectively (HR, 0.76; 95% CI, 0.61-0.94; P = .0053).
The objective response rate (ORR) was 53.0% (95% CI, 45.8%-60.0%), with a complete response (CR) rate of 9.9% and a partial response (PR) rate of 43.1%, in the pembrolizumab arm; in the placebo arm, the ORR was 46.6% (95% CI, 39.6%-53.7%), with a CR rate of 7.8% and a PR rate of 38.7%. The 12- and 18-month duration of response (DOR) rates in the pembrolizumab arm were 46.7% and 28.4% compared with 29.6% and 16.4% in the placebo arm.
At IA1, the median PFS was 8.3 months (95% CI, 7.2-8.6) with pembrolizumab compared with 6.4 months (95% CI, 6.2-8.1) with placebo, with 12-month PFS rates of 33.1% (95% CI, 27.7%-38.5%) and 21.3% (95% CI, 16.6%-26.4%), respectively (HR, 0.70; 95% CI, 0.58-0.84; P <.0001).
At IA2, the median PFS was 8.3 months vs 6.4 months, respectively (HR, 0.73; 95% CI, 0.62-0.86); the 12-month PFS rates were 33.7% vs 22.5%, and the 18-month PFS rates were 17.3% vs 9.0%.
The ORR was 50.4% (95% CI, 44.3%-56.4%), with a CR rate of 8.3% and a PR rate of 42.0%, in the pembrolizumab arm; in the placebo arm, the ORR was 40.8% (95% CI, 35.0%-46.8%), with a CR rate of 6.0% and a PR rate of 34.8%.Furthermore, the 12- and 18-month DOR rates in the pembrolizumab arm were 46.6% and 26.5% compared with 28.4% and 14.5% in the placebo arm.
“These data support the use of pembrolizumab plus weekly paclitaxel, with or without bevacizumab, as a new standard of care for patients with PRROC,” presenting author Nicoletta Colombo, MD, PhD, of the Gynecologic Oncology Program at the European Institute of Oncology, IRCCS, in Milan, Italy, and the Department of Medicine and Surgery at the University of Milan-Bicocca in Italy, wrote with coauthors in the presentation.
Any-grade treatment-related adverse events (TRAEs) occurred in 97.8% of the pembrolizumab arm and 95.3% of the placebo arm; grade 3 or higher TRAEs occurred in 67.5% and 55.3%, respectively. TRAEs were serious in 33.1% and 19.5%, led to death in 0.9% and 1.6%, and led to discontinuation of any treatment in 35.9% and 28.0%.
Any-grade immune-mediated AEs occurred in 39.1% and 18.9%, and grade 3 or higher events occurred in 11.6% and 3.5%. They were serious events in 10.9% and 2.2%, and led to treatment discontinuation in 6.9% and 2.5%.
The most common TRAEs in both groups included anemia (49.7% vs 42.1%, respectively), peripheral neuropathy (38.8% vs 31.1%), alopecia (37.8% vs 34.0%), fatigue (35.3% vs 33.0%), and nausea (31.3% vs 27.4%). The most common immune-mediated AEs were hypothyroidism (17.8% vs 6.0%), infusion reactions (5.9% vs 4.7%), and hyperthyroidism (5.0% vs 0.6%).
A total of 643 patients with histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma were enrolled in the trial and randomly assigned to either the pembrolizumab arm (n = 322) or the placebo arm (n = 321). Treatment was either pembrolizumab at 400 mg once every 6 weeks for 18 cycles or placebo on the same schedule; all patients received paclitaxel at 80 mg/m2 on days 1, 8, and 15 of each 3-week-long cycle, and they either did or did not receive bevacizumab at 10 mg/kg every 2 weeks.
Patients were enrolled in the trial if they had received 1 or 2 prior lines of therapy with at least 1 platinum-based chemotherapy; prior anti-PD-1 or anti-PD-L1 agents, PARP inhibitors, and bevacizumab were permitted. Additionally, patients had radiographic progression within 6 months after the last dose of platinum-based chemotherapy and an ECOG performance status of 0 or 1.
The primary end point of the trial was PFS per RECIST v1.1 by investigator assessment, and a key secondary end point was OS.
The median age of patients was 62 years vs 61 years in the pembrolizumab vs placebo arm, 64.3% and 67.6% of patients were White, 41.3% and 41.1% had a PD-L1 CPS from 1 to less than 10, and 31.4% and 31.2% had a PD-L1 CPS of at least 10.
Colombo N, Zsiros E, Sebastianelli A, et al. Pembrolizumab vs placebo plus weekly paclitaxel ± bevacizumab in platinum-resistant recurrent ovarian cancer: Results from the randomized double-blind phase 3 ENGOT-ov65/KEYNOTE-B96 study. Presented at: European Society of Medical Oncology Congress 2025; October 17–20, 2025; Berlin, Germany. Abstract LBA3.
Gold price fell slightly on Friday, October 17, but ended the week with the biggest rise since 2020. Gold futures dropped over 1% to around $4,260 an ounce after hitting an intraday high of $4,380. Despite the dip, gold was up 7% for the week as investors bought the precious metal amid uncertainty, Yahoo Finance reported.
Kyle Rodda, senior financial market analyst, said a “perfect storm” of global factors has pushed gold prices higher. Rising trade tensions between the United States and China, expectations of another Federal Reserve rate cut, and worries about regional banks have all driven investors toward safe-haven assets like gold.
Rodda, who is a market analyst at Capital.com, described the surge as “parabolic,” noting that prices have risen unusually fast. “Gold is sending an ominous message about the future,” he said. “It could be pointing to global instability or a sign of speculation that might burst later.”
Gold’s year-to-date performance has been remarkable, up nearly 59%. Central banks worldwide have been buying gold at record levels, while a weaker US dollar and falling interest rates have made holding gold more attractive than cash or bonds.
At the same time, gold-backed exchange-traded funds (ETFs) saw record inflows last quarter, highlighting strong appetite from both retail and institutional investors.
A Bank of America Fund Managers Survey recently found that gold is the most crowded trade in the market, beating out the “Magnificent Seven” tech stocks. 39% of fund managers have no gold, 35% have 2-4% of their portfolio in gold.
Also Read: Gold, silver prices hit records on US credit fears and ‘US-China trade war’
Several major banks have lifted their gold price targets. BofA analysts reiterated their “long gold” call, predicting prices could reach $6,000 per ounce by mid-2026. Goldman Sachs raised its forecast to $4,900 by the end of next year, and JPMorgan expects prices could climb to $6,000 by 2029.
For now, gold’s upsurge is due to global uncertainty and investor nervousness. Whether it continues or becomes a bubble will depend on how central banks and the world economies react to inflation, rate cuts and geopolitical risks in the coming months.
Also Read: No Kings protests to sweep US as millions plan to march against Trump’s policies
Gold prices rose due to trade tensions, rate-cut expectations, and worries about banks, making investors buy gold as a safe option.
Gold futures reached an intraday high of around $4,380 an ounce before ending the week near $4,260.
Experts say prices may rise further if global uncertainty, inflation, and interest rate cuts continue, but some warn it could become a bubble.
Rachel Leingang
Millions are expected to show out for protests on Saturday at more than 2,500 locations across America, from small towns to large cities, to speak against the Trump administration.
At the ESMO Congress 2025 in Berlin, Dr. Yelena Y. Janjigian (Memorial Sloan Kettering Cancer Center, New York, USA) presented updated long-term results from the Phase II EDGE Gastric study (NCT05329766), sponsored by Arcus Biosciences and Gilead Sciences. The trial evaluated the dual immune checkpoint blockade of domvanalimab (Dom)—an Fc-silent anti-TIGIT antibody developed by Arcus—and zimberelimab (Zim)—an anti–PD-1 antibody—in combination with FOLFOX chemotherapy in the first-line (1L) treatment of HER2-negative advanced gastric (GC), gastroesophageal junction (GEJC), and esophageal adenocarcinoma (EAC).
At a 26-month follow-up, the combination demonstrated durable efficacy, achieving a median overall survival (OS) of 26.7 months and median progression-free survival (PFS) of 13.2 months, reinforcing dual PD-1/TIGIT blockade as a promising next-generation immunotherapy strategy for upper gastrointestinal adenocarcinomas.
Despite advances in immunotherapy, long-term outcomes for patients with advanced gastric and GEJ cancers remain poor. While PD-1 inhibitors have become a mainstay of first-line therapy, resistance and limited response durability remain major challenges.
The TIGIT pathway, a key regulator of T-cell exhaustion, has emerged as a complementary target to PD-1, with potential to deepen and sustain immune responses.
The EDGE-Gastric trial (Arm A1) was designed to assess whether dual inhibition of PD-1 and TIGIT, combined with chemotherapy, could enhance anti-tumor immunity and improve survival outcomes in this population.
Patients received:
Primary endpoints included safety and objective response rate (ORR) by RECIST v1.1, while secondary endpoints assessed progression-free survival (PFS) and overall survival (OS).
A total of 41 patients were enrolled, 63% of whom had gastric cancer.
The median follow-up at data cutoff (March 3, 2025) was 26.4 months.
The combination of Dom + Zim + FOLFOX continued to yield durable and consistent efficacy:
The benefit was consistent across PD-L1 subgroups:
These findings highlight robust, long-lasting responses, particularly in PD-L1–high tumors, with durable benefit extending beyond two years.
The safety profile of Dom + Zim + FOLFOX remained manageable and comparable to PD-1–based chemotherapy regimens.
The regimen demonstrated a favorable safety profile and consistent benefit across PD-L1 subgroups, establishing a strong rationale for phase III validation.
The ongoing STAR-221 trial (NCT05568095) will compare Dom + Zim + chemotherapy directly with nivolumab + chemotherapy in the same setting.
You Can Also Raed INTEGRATE IIb Trial at ESMO 2025: Regorafenib Plus Nivolumab vs Chemotherapy in Advanced Gastric and GEJ Cancer by OncoDaily
You can read the full abstract here
During the treatment period, the proportion of patients who developed at least one SPT was 11% in the cemiplimab arm (n = 209) compared with 12% in the placebo arm (n = 206); during the study’s follow-up period, these rates were 8% and 7%, respectively. During the treatment period, the cumulative number of SPTs was 32 with cemiplimab vs 82 for placebo, corresponding to annualized, adjusted annualized SPT rates of 1.23 (95% CI, 0.60-2.54) and 2.81 (95% CI, 1.23-6.45), respectively. In the follow-up period, 36 total SPTs occurred in the cemiplimab arm vs 41 in the placebo arm, and the annualized SPT rates were 0.72 (95% CI, 0.30-1.71) and 1.17 (95% CI, 0.40-3.49), respectively.
During the treatment period, 9% of patients in the cemiplimab arm had 1 SPT, 1% had 2 SPTs, less than 1% had 3 SPTs, 0% had 4 SPTs, less than 1% had 5 SPTs, and 0% had 6 or more SPTs. In the placebo arm, these rates were 8%, 2%, less than 1%, less than 1%, 0%, and 1%, respectively. Incidence was similar during the follow-up period, with 4% of patients in each arm experiencing 1 SPT and less than 1% of patients falling into the multiple SPT groups within each arm.
In a post hoc analysis incorporating the first occurrence of SPTs alongside disease-free survival (DFS) events (recurrence or death), efficacy continued to favor cemiplimab over placebo (HR, 0.43; 95% CI, 0.30-0.60). The median DFS in this analysis was not reached (NR; 95% CI, not evaluable [NE]-NE) in the cemiplimab group vs 21.7 months (95% CI, 12.9-39.2) in the placebo group. At 24 months, DFS rates were 81.1% with cemiplimab vs 59.1% with placebo, and this benefit was maintained over time, with rates of 73.4% vs 48.7% at 36 months and 68.4% vs 41.5% at 48 months, respectively.
“The lower number of SPTs in the cemiplimab arm appeared to be driven by a small number of patients with multiple SPTs observed in the placebo arm. The robust [DFS] efficacy signal with cemiplimab vs placebo was maintained in a post hoc analysis in which SPTs were included as [DFS] events,” Danny Rischin, MD, who serves as the director of Medical Oncology at the Peter MacCallum Cancer Centre in Melbourne, Australia, noted in the conclusion of his presentation. “These prospective, randomized data suggest that there may be a subset of patients who experience fewer SPTs with cemiplimab, although further investigation is required.”
With a median follow-up of 24 months (range, 2-64), previously reported findings from the primary analysis showed that patients who received adjuvant cemiplimab after surgical resection and postoperative radiotherapy achieved a median DFS that was NR (95% CI, NE-NE) compared with 49.4 months (95% CI, 48.5-NE) among those treated with placebo (n = 206; HR, 0.32; 95% CI, 0.20-0.51; P < .001). The estimated 24-month DFS rates were 87.1% (and 64.1%, respectively.
Based on those findings, on October 8, 2025
The phase 3 C-POST trial is a randomized, double-blind, placebo-controlled study designed to evaluate adjuvant cemiplimab in patients with histologically confirmed CSCC who had undergone complete resection with curative intent and completed postoperative radiotherapy.1 Patients were required to have high-risk features, which included nodal extracapsular extension with at least one lymph node measuring 20 mm or more, or three or more involved lymph nodes; in-transit metastases; perineural invasion; T4 lesions; or recurrent CSCC with 1 or more additional high-risk characteristics.
Participants were randomly assigned 1:1 to receive cemiplimab or placebo. In part 1 of the study, patients received cemiplimab at 350 mg intravenously every 3 weeks for 12 weeks, followed by cemiplimab at 700 mg every 6 weeks for an additional 36 weeks. Those in the control group received matched placebo on the same schedule. Treatment continued until completion of the planned duration, disease recurrence, or unacceptable toxicity.
Patients who experienced recurrence after completing placebo treatment or after at least three months following cemiplimab completion were eligible to enter an optional open-label extension phase (part 2) to receive cemiplimab at 350 mg every 3 weeks for up to 96 weeks.
The primary end point of the trial was DFS. Key secondary end points include freedom from locoregional recurrence, freedom from distant recurrence, cumulative occurrence of second primary tumors, overall survival, and safety.
The median age of patients was 71.0 years (range, 33-87) in the cemiplimab group and 70.5 years (range, 36-95) in the placebo group. Most patients were 65 years of age or older, representing 73% and 68% of each respective arm. The majority of participants were male (83% in both arms) and White (90% vs 92%).
Geographically, 43% of patients in the cemiplimab arm and 44% in the placebo arm were enrolled from Australia or New Zealand, 18% and 15% were from North America, and 39% and 41% were from the rest of the world.
Most patients had resected high-risk tumors located in the head and neck region (79% in the cemiplimab group vs 86% in the placebo group), and 21% and 14% had non–head and neck tumors, respectively. Regarding risk classification, 60% of patients in the cemiplimab arm and 57% in the placebo arm were categorized as having nodal high-risk disease; 40% and 43%, respectively, had non-nodal high-risk features.
Disclosures: Rischin reported receiving institutional research funding from ALX Oncology, AstraZeneca, Bicara Therapeutics, Decibel Therapeutics, Erasca, Marck, and Regeneron Pharmaceuticals; and having uncompensated relationships with Eisai, GSK, Merck, and Regeneron Pharmaceuticals.