Pembrolizumab
- Generic Name
- Pembrolizumab
- Brand Names
- Keytruda
- Drug Type
- Biotech
- CAS Number
- 1374853-91-4
- Unique Ingredient Identifier
- DPT0O3T46P
- Background
Pembrolizumab is a highly selective IgG4-kappa humanized monoclonal antibody against PD-1 receptors. It was generated by grafting the variable sequences of a very high-affinity mouse antihuman PD-1 antibody onto a human IgG4-kappa isotype containing a stabilizing S228P Fc mutation. It contains 32 cysteine residues and the complete folded molecule includes 4 disulfide linkages as interchain bonds and 23 interchain bonds. It was developed by Merck & Co and first approved for the treatment of metastatic malignant melanoma by the FDA on September 4, 2014, becoming the first approved therapy against PD-1. In the time since its initial approval, pembrolizumab has been granted approval in the treatment of a wide variety of cancers.
- Indication
Pembrolizumab is indicated for the following conditions:
For all approved adult indications, pembrolizumab may be used for an additional 6 weeks at 400mg weekly.
- Associated Conditions
- Advanced Endometrial Cancer, Advanced Renal Cell Carcinoma, Hepatocellular Carcinoma, Locally Advanced Cutaneous Squamous Cell Carcinoma, Locally Advanced or Metastatic Urothelial Carcinoma (UC), Metastatic Adenocarcinoma of the Gastroesophageal Junction, Metastatic Cervical Cancer, Metastatic Esophageal Carcinoma, Metastatic Melanoma, Metastatic Non-Small Cell Lung Cancer, Metastatic Renal Cell Carcinoma ( mRCC), Metastatic Squamous Cell Carcinoma of the Head and Neck (HNSCC), Metastatic Triple Negative Breast Cancers, Metastatic Urothelial Carcinoma (UC), Metastatic cutaneous squamous cell carcinoma, Metastic Renal Cell Carcinoma, Non-Small Cell Lung Cancer (NSCLC), Nonsmall Cell Lung Cancer, Stage II, Persistent Cervical Cancer, Recurrent Cervical Cancer, Refractory Primary Mediastinal Large B-Cell Cell Lymphoma, Renal Cell Carcinoma (RCC), Resectable Non-small Cell Lung Cancer, Stage IB Non-small Cell Lung Cancer, Stage IIB Melanoma, Stage IIC Melanoma, Stage III Melanoma, Stage IIIA Non Small Cell Lung Cancer, Unresectable Melanoma, Advanced Microsatellite Instability High Endometrial Carcinoma, Advanced Mismatch Repair-deficient (dMMR) Endometrial Carcinoma, High risk, early Triple Negative Breast Cancer, High risk, in situ Non-Muscle Invasive Bladder Cancer (NMIBC) Refractory to BCG, Locally advanced Adenocarcinomas of the Gastroesophageal Junction, Locally advanced Esophageal Carcinoma, Locally advanced Urothelial Carcinoma, Metastatic HER2-positive Adenocarcinoma of the Stomach, Metastatic HER2-positive Adenocarcinomas of the Gastroesophageal Junction, Metastatic High Tumor Mutation Burden Solid Tumors, Metastatic Merkel Cell Carcinoma (MCC), Metastatic Microsatellite Instability High Colorectal Cancer, Metastatic Microsatellite Instability-High (MSI-H) Solid Tumors, Metastatic Mismatch Repair Deficient Colorectal Cancer, Metastatic Mismatch repair deficient (dMMR) solid tumors, Recurrent Cutaneous Squamous Cell Carcinoma, Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN), Recurrent, locally advanced Adenocarcinomas of the Gastroesophageal Junction, Recurrent, locally advanced Merkel Cell Carcinoma, Refractory Classical Hodgkin's Lymphoma, Relapsed Classical Hodgkin's Lymphoma, Stage 3 Non-Small Cell Lung Carcinoma (NSCLC), Unresectable High Tumor Mutation Burden Solid Tumors, Unresectable Microsatellite Instability High Colorectal Cancer, Unresectable Microsatellite Instability-High (MSI-H) Solid Tumors, Unresectable Mismatch Repair Deficient Colorectal Cancer, Unresectable Mismatch repair deficient (dMMR) solid tumors, Unresectable, locally advanced HER2-positive Adenocarcinoma of the Stomach, Unresectable, locally advanced HER2-positive Adenocarcinomas of the Gastroesophageal Junction, Unresectable, locally recurrent Triple Negative Breast Cancer, Unresectable, recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)
CCM Biosciences to Present Breakthrough 4th-Generation EGFR Inhibitors for NSCLC at ASCO 2025
• CCM Biosciences will present data on novel 4th-generation EGFR inhibitors (CCM-205, CCM-245, and CCM-308) that overcome both mutational and non-mutational resistance to 3rd-generation inhibitors in NSCLC at ASCO 2025.
• The company's compounds significantly outperform other investigational 4th-generation inhibitors in various drug resistance models and show efficacy as both monotherapies and in combination with existing treatments.
• CCM Biosciences plans to file an Investigational New Drug (IND) application this year to advance clinical candidates from its EGFR inhibitor program into clinical trials.
Pfizer Enters $6 Billion Licensing Deal with China's 3SBio for Novel Cancer Drug
• Pfizer has secured global rights (excluding China) to 3SBio's experimental cancer drug SSGJ-707 for $1.25 billion upfront, with potential additional payments of up to $4.8 billion based on developmental milestones.
• SSGJ-707 is currently being evaluated for multiple cancer types including non-small cell lung cancer, metastatic colorectal cancer, and gynecological tumors, with Phase III trials in China planned to begin this year.
• The deal includes a $100 million equity investment in 3SBio by Pfizer, with manufacturing planned at Pfizer's facilities in North Carolina and Kansas following FDA clearance of the Investigational New Drug application.
CytomX Doses First Patient in Combination Trial of CX-801 with Keytruda for Metastatic Melanoma
• CytomX Therapeutics has dosed the first patient in a Phase 1 trial combining its masked interferon alpha-2b (CX-801) with Merck's Keytruda in patients with metastatic melanoma.
• The novel combination aims to address the high unmet need in PD-1 refractory melanoma by localizing interferon's potent immune-stimulating effects to tumors while minimizing systemic toxicities.
• Initial Phase 1a translational and biomarker data from this study are expected in the second half of 2025, potentially advancing a new approach in combination immuno-oncology therapy.
Astellas to Present New Long-Term Survival Data for Cancer Therapies at ASCO 2025
• Astellas will showcase 16 abstracts at the 2025 ASCO Annual Meeting, including two oral presentations highlighting long-term survival data for its oncology portfolio.
• New post-hoc analyses will feature five-year overall survival data for XTANDI (enzalutamide) in metastatic hormone-sensitive prostate cancer and exploratory analyses for PADCEV (enfortumab vedotin) in urothelial cancer.
• The presentations underscore Astellas' commitment to delivering meaningful clinical outcomes for patients with advanced prostate and bladder cancers through innovative treatment approaches.
Colorectal Cancer Leads in Real-World Data Volume, But Oncology Trials Need Modernization
• Phesi's analysis of 167 million patient records reveals colorectal cancer has the largest volume of real-world data with nearly six million records, outpacing breast, lung, liver, and prostate cancers.
• Despite the wealth of available data, oncology clinical trials continue to suffer from inefficiencies, with trial design and execution failing to keep pace with advances in biomarker science and patient profiling.
• Experts urge a shift toward "precision oncology" using AI and clinical data science to optimize patient profiles, programs, protocols, and operations plans to accelerate drug development.
US Orphan Drug Market Set to Exceed $190 Billion by 2030 as FDA Designations Accelerate
• The US orphan drug market is projected to surpass $190 billion by 2030, with over 7,300 molecules receiving FDA Orphan Drug Designation to date, of which approximately 17.9% have gained approval.
• Since 2020, more than half of all new drug approvals by the FDA's Center for Drug Evaluation and Research have been granted orphan status, highlighting the growing importance of rare disease treatments in pharmaceutical development.
• Despite criticism over high pricing, exemplified by Abeona Therapeutics' Zevaskyn at $3.1 million per treatment, the orphan drug model has evolved into a sound business strategy offering fewer competitors, faster approvals, and seven-year market exclusivity.
Antengene to Showcase Six Innovative Cancer Therapies at AACR and ASCO 2025
• Antengene will present data from four preclinical studies at AACR 2025, featuring novel T-cell engagers and a synthetic lethality approach targeting MTAPnull cancers.
• The company's ATG-201 (CD19 x CD3 TCE) and ATG-042 (MTAPnull-selective PRMT5 inhibitor) demonstrated promising efficacy in preclinical models and are poised to enter clinical development in the second half of 2025.
• At ASCO 2025, Antengene will share clinical data on ATG-037 (CD73 inhibitor) in combination with pembrolizumab for anti-PD-1 resistant solid tumors, with encouraging preliminary results in melanoma and NSCLC.
Sylvester Comprehensive Cancer Center to Present Groundbreaking Research at ASCO 2025 Annual Meeting
• Researchers from Sylvester Comprehensive Cancer Center will deliver 9 oral presentations, 4 rapid oral presentations, and 51 poster presentations at the upcoming ASCO 2025 Annual Meeting, showcasing significant advances across multiple cancer types.
• Highlighted studies include the ADVANCE clinical trial examining novel multiple myeloma treatments, innovative virtual reality interventions for stem cell transplant patients, and groundbreaking research on alcohol-related cancer mortality in the US.
• The extensive research portfolio demonstrates Sylvester's leadership in developing cutting-edge cancer therapies, addressing health disparities, and improving supportive care for diverse patient populations.
Balancing Efficacy and Cost Sustainability in Modern CLL Treatment: Insights from Dr. Pierluigi Porcu
• Clinicians treating chronic lymphocytic leukemia (CLL) face growing challenges in balancing clinical efficacy with long-term cost sustainability, requiring a holistic approach to patient care.
• Dr. Pierluigi Porcu emphasizes that effective CLL management requires understanding disease risk, patient comorbidities, and practice environment constraints including payer considerations.
• Despite its importance, value-based care adoption remains insufficient in oncology, with challenges in defining and measuring value across patient outcomes, quality of life, and treatment costs.
Merck Unveils $1B Vaccine Manufacturing Facility in North Carolina
• Merck has opened a new $1 billion, 225,000-square-foot vaccine manufacturing facility in Durham, North Carolina, expanding its domestic production capabilities.
• The investment is part of Merck's broader $12 billion U.S. capital investment strategy since 2018, with plans to invest an additional $8 billion by 2028.
• The expansion comes amid political pressure to increase domestic pharmaceutical manufacturing, as the Biden administration considers imposing tariffs on pharmaceutical imports.
PADCEV-KEYTRUDA Combination Shows Sustained Survival Benefit in Advanced Urothelial Cancer Trial
• Phase 3 EV-302 trial demonstrates PADCEV plus KEYTRUDA reduces mortality risk by 49% compared to chemotherapy in advanced urothelial cancer patients, with median overall survival of 33.8 months versus 15.9 months.
• The combination therapy showed significant progression-free survival benefit of 12.5 months compared to 6.3 months with chemotherapy, representing a 52% reduction in disease progression risk.
• Extended 12-month follow-up data confirms sustained efficacy across all patient subgroups, including both cisplatin eligible and ineligible patients, with no new safety concerns identified.
BioNTech Advances Oncology Pipeline with BNT327/PM8002 and mRNA Immunotherapies
• BioNTech is progressing BNT327/PM8002, a bispecific antibody, into global clinical trials for first-line small cell lung cancer and non-small cell lung cancer.
• The company plans to initiate additional trials combining BNT327/PM8002 with antibody-drug conjugates (ADCs) in 2025, expanding its combination strategy.
• BioNTech's mRNA cancer immunotherapy, autogene cevumeran, is being evaluated in a Phase 2 trial for muscle-invasive urothelial carcinoma in combination with nivolumab.
• Clinical data readouts are expected in 2025 and 2026 from multiple randomized trials of personalized and off-the-shelf mRNA cancer immunotherapy candidates.
mRNA Cancer Vaccines Show Promise in Clinical Trials, Aiming for Personalized Immunotherapy
• Over 60 mRNA cancer vaccine candidates are in clinical trials, signaling a transformative shift in cancer treatment.
• BioNTech's BNT111, targeting melanoma-associated antigens, shows positive Phase 2 data when combined with cemiplimab.
• Personalized mRNA vaccines, like Moderna's mRNA-4157, are being explored in combination with PD-1 therapies for various cancers.
• The first commercial mRNA cancer vaccine is expected by 2029, driven by technological advancements and increased investment.
AbbVie's Telisotuzumab Vedotin Shows Promise in c-Met Overexpressing NSCLC
• AbbVie's telisotuzumab vedotin (Teliso-V) demonstrated a 35% overall response rate in patients with high c-Met expression in the LUMINOSITY trial.
• The FDA granted breakthrough therapy designation to Teliso-V, highlighting its potential to significantly improve outcomes in NSCLC patients.
• A phase 3 trial (TeliMET-NSCLC-01) is underway, comparing Teliso-V to docetaxel in c-Met-positive, non-squamous NSCLC patients.
• Teliso-V targets c-Met, a protein involved in cancer progression and resistance to therapies like EGFR inhibitors, offering a novel approach.
Alpha Tau's Alpha DaRT Therapy Receives FDA Nod for Expanded Pancreatic Cancer Trial
• The FDA has approved an IDE supplement for Alpha Tau, expanding the Alpha DaRT trial to include locally advanced pancreatic cancer patients.
• The trial will now enroll a total of 30 patients across two cohorts, each with 15 participants, at up to 10 clinical sites in the U.S.
• This expansion follows promising data on disease control and overall survival in pancreatic cancer patients treated with Alpha DaRT.
• Alpha Tau's CEO welcomes the IDE supplement, emphasizing the company's commitment to exploring new treatments for this deadly disease.
Camrelizumab and Apatinib Show Promise in Neoadjuvant Treatment of TNBC
• Camrelizumab plus chemotherapy significantly improved pathologic complete response (pCR) rates in early or locally advanced triple-negative breast cancer (TNBC).
• Apatinib combined with sintilimab and chemotherapy demonstrated a high pCR rate of 70.6% in early TNBC, suggesting synergistic effects.
• Both camrelizumab and apatinib regimens exhibited manageable safety profiles, supporting their potential as new neoadjuvant therapeutic options.
• Biomarker analysis in the apatinib study identified correlations between immune response and pCR, offering insights for predicting treatment efficacy.
BioNTech's Bispecific Antibody BNT-327 Shows Promise in Triple-Negative Breast Cancer
• BioNTech's BNT-327, a bispecific antibody targeting PD-L1 and VEGF, has demonstrated positive early results in patients with triple-negative breast cancer.
• The bispecific antibody builds on the success of checkpoint inhibitors like Keytruda, potentially representing the next generation of immunotherapy drugs.
• Early trial data, presented at the San Antonio Breast Cancer Symposium, suggest BNT-327 could become a critical component in treating triple-negative breast cancer.
• The development of BNT-327 aligns with a broader interest in PD1/PD-L1 and anti-VEGF bispecifics, following promising results from Summit Therapeutics in lung cancer.
Keytruda/Lenvima Combo Shows Mixed Results in Gastroesophageal Adenocarcinoma Trial
• The Phase 3 LEAP-015 trial evaluated Keytruda plus Lenvima with chemotherapy for HER2-negative gastroesophageal adenocarcinoma.
• The combination significantly improved progression-free survival and objective response rate compared to chemotherapy alone.
• However, the trial failed to meet its other primary endpoint of overall survival in the final analysis.
• The safety profile of the Keytruda plus Lenvima regimen was consistent with prior studies.
Niraparib Shows Promise in Extending Progression-Free Survival in Epithelial Ovarian Cancer
• Niraparib monotherapy extends real-world progression-free survival (rwPFS) and time to next treatment (rwTTNT) in patients with epithelial ovarian cancer (EOC).
• Patients with homologous recombination-deficient (HRd) tumors, particularly those with BRCA-mutated tumors, experienced longer rwPFS and rwTTNT.
• Niraparib demonstrates clinical benefit in stage III EOC patients with no visible residual disease (NVRD) after primary cytoreductive surgery (PCS).
• Niraparib stands out among PARP inhibitors for its broad frontline maintenance therapy approval in EOC, regardless of BRCA mutation or HRD status.
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