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Pembrolizumab - 8 cycle
Pembrolizumab - 8 cycle is a PD-1 inhibitor Small molecule drug developed by QuantumLeap Healthcare Collaborative. It is currently in Phase 2 development for Non-small cell lung cancer, Melanoma, Head and neck squamous cell carcinoma.
PD-1 inhibitor
Pembrolizumab is a medication used to treat various types of cancer, including Esophageal Squamous Cell Carcinoma, Non-small Cell Lung Cancer, Relapsed Diffuse Large B-cell Lymphoma, and Refractory Diffuse Large B-cell Lymphoma. It is often used in combination with other treatments, such as Paclitaxel and Irinotecan, as part of clinical trials to evaluate its effectiveness in treating Solid Tumors.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 2 attrition
-2.0pp
Oncology drugs have higher Phase 2-to-Phase 3 attrition than average — many fail to show OS benefit in larger studies.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Pembrolizumab - 8 cycle |
|---|---|
| Sponsor | QuantumLeap Healthcare Collaborative |
| Drug class | PD-1 inhibitor |
| Target | PD-1 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 2 |
Mechanism of action
Pembrolizumab is a monoclonal antibody that binds to PD-1 on T cells, blocking the interaction with PD-L1 on tumor cells and allowing T cells to attack cancer cells.
Approved indications
- Non-small cell lung cancer
- Melanoma
- Head and neck squamous cell carcinoma
Common side effects
- Pneumonitis
- Hypothyroidism
- Hyperthyroidism
Key clinical trials
- Study BT8009-230 in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2) (PHASE2, PHASE3)
- A Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Triple-Negative Breast Cancer (MK-2870-011/TroFuse-011) (PHASE3)
- Testing the Addition of an Anti-cancer Drug, Pembrolizumab, to the Usual Intravesical Chemotherapy Treatment (Gemcitabine) for the Treatment of BCG-Unresponsive Non-muscle Invasive Bladder Cancer (PHASE2)
- Neoadjuvant Ficerafusp Alfa With Pembrolizumab in Resectable SCC (PHASE2)
- Testing the Addition of the Immunotherapy Drug, Pembrolizumab, to Radiation Therapy Compared to the Usual Chemotherapy Treatment During Radiation Therapy for Bladder Cancer, PARRC Trial (PHASE2)
- Pembrolizumab With or Without Maintenance Sacituzumab Tirumotecan (Sac-TMT; MK-2870) in Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) [MK-2870-023] (PHASE3)
- A Study to Evaluate the Bioavailability of Pembrolizumab (MK-3475) Via Subcutaneous (SC) Injection of Pembrolizumab Formulated With Berahyaluronidase Alfa (MK-5180) [MK-3475A] In Advanced Solid Tumors (MK-3475A-C18) (PHASE1)
- Pembrolizumab and Recombinant Interleukin-12 in Treating Patients With Solid Tumors (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Pembrolizumab - 8 cycle CI brief — competitive landscape report
- Pembrolizumab - 8 cycle updates RSS · CI watch RSS
- QuantumLeap Healthcare Collaborative portfolio CI
Frequently asked questions about Pembrolizumab - 8 cycle
What is Pembrolizumab - 8 cycle?
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What is Pembrolizumab - 8 cycle used for?
Who makes Pembrolizumab - 8 cycle?
What drug class is Pembrolizumab - 8 cycle in?
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Related
- Drug class: All PD-1 inhibitor drugs
- Target: All drugs targeting PD-1
- Manufacturer: QuantumLeap Healthcare Collaborative — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Non-small cell lung cancer
- Indication: Drugs for Melanoma
- Indication: Drugs for Head and neck squamous cell carcinoma
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing