Publications by authors named "Shirong Han"
Background: Part D of the open-label, phase 1 KEYNOTE-011 study (ClinicalTrials.gov, NCT01840579) evaluated the safety and tolerability, pharmacokinetics, and antitumor activity of pembrolizumab plus ipilimumab as first-line treatment in Japanese participants with advanced NSCLC.
Methods: Eligible participants were aged ≥20 years with previously untreated stage IIIB/IV NSCLC (any tumor PD-L1 status permitted).
Article Synopsis
- The study evaluated the effectiveness of pembrolizumab combined with chemotherapy in Japanese patients with advanced esophageal cancer compared to a placebo with chemotherapy, showing improved overall survival (OS) and progression-free survival (PFS) over a median follow-up of 36.6 months.!
- Patients receiving pembrolizumab-chemotherapy exhibited better OS and PFS, particularly those who experienced early tumor shrinkage or significant depth of response, indicating a stronger therapeutic benefit from this combination treatment.!
- The safety profile remained manageable, with a slight increase in severe treatment-related adverse events for the pembrolizumab group, but no new safety concerns emerged during the extended follow-up period.!
Background: Pembrolizumab plus epacadostat (indoleamine 2,3-dioxygenase-1 inhibitor) was well tolerated in Japanese patients with advanced solid tumors in part A of the nonrandomized, open-label, phase 1 KEYNOTE-434 study (NCT02862457). We report results from part B, which evaluated epacadostat plus pembrolizumab and chemotherapy in Japanese patients with advanced non-small-cell lung cancer (NSCLC).
Methods: Eligible patients aged ≥ 20 years had histologically or cytologically confirmed stage IIIB or IV NSCLC with no prior systemic therapy, and ECOG performance status of 0 or 1.
Article Synopsis
- Pembrolizumab showed promising results for treating advanced melanoma in Japanese patients, with a phase 1b trial indicating an overall response rate of 24.3%.
- The study involved 42 patients, with a median follow-up of 22.3 months, revealing a median overall survival of 25.1 months and a 30-month survival rate of 46.3%.
- While 78.6% experienced treatment-related adverse events, the safety profile remained acceptable, with no new treatment-related deaths reported.
Analysis of East Asia subgroup in Study 309/KEYNOTE-775: lenvatinib plus pembrolizumab versus treatment of physician's choice chemotherapy in patients with previously treated advanced or recurrent endometrial cancer.
J Gynecol Oncol
March 2024
Article Synopsis
- Lenvatinib combined with pembrolizumab significantly improved progression-free survival (PFS), overall survival (OS), and objective response rate (ORR) compared to standard chemotherapy in patients with advanced or recurrent endometrial cancer during a global phase 3 trial.
- East Asian patients who received this combination treatment showed favorable outcomes with lower hazard ratios for both PFS and OS than those treated with physician's choice chemotherapy.
- The treatment was associated with high rates of adverse events, but these were mostly manageable, highlighting the benefits of the therapy in this patient demographic.
Background: Part E of the KEYNOTE-011 (NCT01840579) study assessed the safety and antitumor activity of pembrolizumab plus platinum-etoposide chemotherapy in Japanese patients with previously untreated extensive-stage small-cell lung cancer (ES-SCLC).
Methods: Patients received 4 cycles of pembrolizumab (200 mg) every 3 weeks in combination with cisplatin (75 mg/m) and etoposide (100 mg/m; days 1, 2, 3) in cohort 1; with carboplatin (AUC 5 mg/mL/min) and etoposide (100 mg/m; days 1, 2, 3) in cohort 2; or with cisplatin/etoposide and pegfilgrastim (3.6 mg; cycle 1, day 4) in cohort 3.
Article Synopsis
- Pembrolizumab, an anti-PD-1 therapy, showed efficacy in treating gastric/gastroesophageal junction cancer in Japanese patients across multiple study phases (KEYNOTE-059, KEYNOTE-061, and KEYNOTE-062).
- The results indicated varying levels of overall survival (OS), progression-free survival (PFS), and objective response rates (ORR) across the studies, with some advantages over chemotherapy.
- Overall, the findings suggest that pembrolizumab is promising for gastric cancer treatment and further evaluation is warranted.
The KEYNOTE-659 study evaluated the efficacy and safety of first-line pembrolizumab plus S-1 and oxaliplatin (SOX) (cohort 1) or S-1 and cisplatin (SP) (cohort 2) for advanced gastric/gastroesophageal junction (G/GEJ) cancer in Japan. Herein, we update the results of cohort 1 and describe the results of cohort 2. This open-label phase IIb study enrolled patients with advanced programmed death-ligand 1 (PD-L1)-positive (combined positive score ≥ 1) human epidermal growth factor receptor 2 (HER2)-negative G/GEJ adenocarcinoma.
View Article and Find Full Text PDFBackground: The phase 3 KEYNOTE-590 (NCT03189719) study showed first-line pembrolizumab plus chemotherapy significantly prolonged overall survival and progression-free survival versus placebo plus chemotherapy in patients with advanced unresectable or metastatic adenocarcinoma or squamous cell carcinoma of the esophagus or advanced/metastatic Siewert type I adenocarcinoma of the esophagogastric junction. We describe a subgroup analysis of Japanese patients from KEYNOTE-590.
Methods: Eligible patients were randomly assigned 1:1 to pembrolizumab 200 mg intravenously every 3 weeks or placebo plus chemotherapy (cisplatin 80 mg/m and 5-fluorouracil 800 mg/m/day).
Study 309/KEYNOTE-775 is a phase 3 open-label, randomized trial of lenvatinib plus pembrolizumab versus treatment of physician's choice (TPC) in patients with advanced endometrial cancer with progression after platinum-based therapy. Primary endpoints of superiority for lenvatinib plus pembrolizumab were met for progression-free survival (PFS) and overall survival (OS) in all-comers (ie, regardless of mismatch repair [MMR] status) and patients with MMR proficiency (pMMR). We present results for the Japanese subset.
View Article and Find Full Text PDFIntroduction: Pembrolizumab plus chemotherapy significantly improved outcomes over chemotherapy alone as first-line treatment in patients with advanced non-small-cell lung cancer (NSCLC) in phase 3 international trials. In the phase 1 KEYNOTE-011 study (parts B and C), we evaluated the safety/activity of pembrolizumab plus chemotherapy as first-line treatment in Japanese patients with advanced NSCLC.
Methods: Eligible patients received 4 cycles (every 3 weeks) of pembrolizumab 200 mg plus chemotherapy (cisplatin 75 mg/m/carboplatin area under the curve [AUC] 5 mg/mL/min and pemetrexed 500 mg/m in part B [nonsquamous]; carboplatin AUC 6 mg/mL/min and paclitaxel 200 mg/m/nab-paclitaxel 100 mg/m (weekly) in part C [squamous]), followed by maintenance pembrolizumab (and pemetrexed, part B).
Article Synopsis
- Advanced esophageal cancer treatments in Japan are lacking, leading to a study comparing pembrolizumab with chemotherapy as second-line therapy for patients whose cancer progressed after initial treatment.
- The study involved 152 Japanese patients, mostly with squamous cell carcinoma, who were given either pembrolizumab or various chemotherapy options, displaying improved median overall survival for both the full patient group and those with higher PD-L1 scores receiving pembrolizumab.
- Pembrolizumab was found to have a better safety profile, with significantly fewer overall and severe treatment-related adverse events compared to chemotherapy, confirming its benefits in this patient population.