Biologic medicines for cancer MCQs With Answer

Biologic medicines for cancer MCQs With Answer is designed for M.Pharm students specializing in Biological Evaluation of Drug Therapy. This collection focuses on therapeutic biologics used in oncology — including monoclonal antibodies, antibody-drug conjugates, checkpoint inhibitors, cytokines, CAR-T cells, and biosimilars. Each question emphasizes mechanism of action, pharmacokinetics, immunogenicity, safety, preclinical and clinical evaluation, and regulatory considerations relevant to biologic anticancer agents. The set aims to strengthen conceptual understanding and application of advanced topics such as Fc-effector functions, target-mediated drug disposition, potency assays, and management of immune-related adverse events, preparing students for examinations and real-world pharmaceutical development challenges.

Q1. Which of the following best describes the primary mechanism by which trastuzumab exerts antitumor effects in HER2-positive breast cancer?

• Inhibition of VEGF-mediated angiogenesis
• Blockade of HER2 receptor dimerization and induction of antibody-dependent cellular cytotoxicity (ADCC)
• Direct alkylation of DNA in tumor cells
• Activation of CTLA-4 to suppress regulatory T cells

Correct Answer: Blockade of HER2 receptor dimerization and induction of antibody-dependent cellular cytotoxicity (ADCC)

Q2. Target-mediated drug disposition (TMDD) for monoclonal antibodies is primarily caused by which process?

• Non-specific renal filtration due to small molecular size
• High-affinity binding to a membrane antigen with subsequent internalization and catabolism
• Hepatic cytochrome P450 metabolism
• Passive diffusion across the blood-brain barrier

Correct Answer: High-affinity binding to a membrane antigen with subsequent internalization and catabolism

Q3. Which feature of an antibody-drug conjugate (ADC) most directly affects the potency and bystander killing effect?

• The isotype of the IgG Fc region
• The drug-to-antibody ratio (DAR) and payload mechanism of action
• The cell line used for mAb production
• The formulation buffer pH

Correct Answer: The drug-to-antibody ratio (DAR) and payload mechanism of action

Q4. Which adverse event is most characteristically associated with CAR-T cell therapy and often managed with tocilizumab?

• Interstitial lung disease
• Cytokine release syndrome (CRS)
• Progressive multifocal leukoencephalopathy
• Nephrotoxicity

Correct Answer: Cytokine release syndrome (CRS)

Q5. Which modification is commonly used to extend the half-life of therapeutic proteins via neonatal Fc receptor (FcRn) recycling?

• Site-directed mutagenesis to enhance Fc-FcRn affinity at acidic pH
• Removal of all N-linked glycans
• Conjugation to a radioactive tracer
• Increased hydrophobicity of the variable region

Correct Answer: Site-directed mutagenesis to enhance Fc-FcRn affinity at acidic pH

Q6. In preclinical evaluation of an anticancer biologic, which in vivo model is most appropriate to assess human-targeted antibody efficacy when the target is human-specific?

• Syngeneic murine tumor model with mouse target expression
• Human tumor xenograft in immunodeficient mice bearing human antigen
• Rat toxicology model focused on kidney function
• Non-human primate with no expression of target antigen

Correct Answer: Human tumor xenograft in immunodeficient mice bearing human antigen

Q7. Which analytical critical quality attribute (CQA) is most relevant for biosimilarity assessment of monoclonal antibody biologics?

• Exact nucleotide sequence of expression plasmid
• Glycosylation profile, charge variants, and binding potency
• Type of sterile filter used during filling
• Color of the final drug product

Correct Answer: Glycosylation profile, charge variants, and binding potency

Q8. Checkpoint inhibitors such as nivolumab target which immune checkpoint to enhance antitumor T-cell activity?

• VEGFR-2
• Programmed cell death protein 1 (PD-1)
• HER2 receptor
• CD20 B-cell antigen

Correct Answer: Programmed cell death protein 1 (PD-1)

Q9. Which of the following best explains why monoclonal antibodies typically have limited penetration into solid tumor cores?

• Active efflux by tumor MDR transporters
• Large molecular size and binding-site barrier combined with high interstitial pressure
• High passive diffusion through tumor vasculature
• Rapid renal clearance preventing accumulation

Correct Answer: Large molecular size and binding-site barrier combined with high interstitial pressure

Q10. Immunogenicity of biologic anticancer agents is most commonly evaluated clinically by measuring:

• Neutralizing and binding anti-drug antibodies (ADAs) and their impact on PK/PD and safety
• Serum creatinine and liver enzymes only
• Complete blood counts weekly for one year
• Electrocardiogram changes post-infusion

Correct Answer: Neutralizing and binding anti-drug antibodies (ADAs) and their impact on PK/PD and safety

Q11. Which linker characteristic in an ADC favors release of payload specifically inside tumor cells while minimizing systemic release?

• Highly stable linker cleaved only by intracellular lysosomal proteases or acidic pH
• Linker that spontaneously hydrolyzes in plasma
• Non-cleavable linker that releases payload upon mild heating
• Extremely hydrophobic linker promoting plasma protein binding

Correct Answer: Highly stable linker cleaved only by intracellular lysosomal proteases or acidic pH

Q12. Which regulatory pathway allows earlier approval of oncology biologics based on surrogate endpoints reasonably likely to predict clinical benefit?

• Full traditional approval with randomized overall survival requirement
• Accelerated approval using surrogate endpoints such as objective response rate
• Orphan drug designation without clinical data
• Over-the-counter switch approval

Correct Answer: Accelerated approval using surrogate endpoints such as objective response rate

Q13. Which of the following Fc-mediated functions is primarily responsible for complement-dependent cytotoxicity (CDC)?

• Binding to FcRn at acidic pH
• Recruitment of C1q to IgG Fc and activation of the classical complement cascade
• Direct blockade of ligand-receptor interactions by Fab
• Endosomal recycling of the antibody

Correct Answer: Recruitment of C1q to IgG Fc and activation of the classical complement cascade

Q14. When selecting a first-in-human (FIH) dose for a novel oncology biologic, the MABEL approach stands for:

• Maximum Assayed Biological and Exposure Level
• Minimal Anticipated Biological Effect Level
• Major Adverse Biologic Event Limit
• Most Adequate Baseline Exposure Level

Correct Answer: Minimal Anticipated Biological Effect Level

Q15. Which strategy is used to reduce immunogenicity of therapeutic antibodies derived from non-human species?

• Chimerization or humanization of variable regions to reduce murine sequences
• Increasing the number of non-human glycans
• Adding foreign protein tags for detection
• Using stronger adjuvants in formulation

Correct Answer: Chimerization or humanization of variable regions to reduce murine sequences

Q16. Which analytical assay directly measures functional potency of a cytotoxic ADC in vitro?

• Size-exclusion chromatography for aggregation
• Cell-based cytotoxicity assay (e.g., viability or apoptosis readout in target-positive cells)
• SDS-PAGE glycan staining
• Endotoxin LAL assay

Correct Answer: Cell-based cytotoxicity assay (e.g., viability or apoptosis readout in target-positive cells)

Q17. Which of the following is a common neurological toxicity associated with some CAR-T therapies and is managed primarily with corticosteroids?

• Infusion-related hypersensitivity reaction
• Immune effector cell-associated neurotoxicity syndrome (ICANS)
• Hepatotoxicity with elevated transaminases
• Peripheral neuropathy related to vinca alkaloids

Correct Answer: Immune effector cell-associated neurotoxicity syndrome (ICANS)

Q18. Which production cell line is most commonly used for large-scale commercial manufacture of therapeutic monoclonal antibodies due to human-like glycosylation and scalability?

• Escherichia coli expression system
• Chinese hamster ovary (CHO) cells
• Baculovirus-infected insect cells exclusively
• Yeast Pichia pastoris system exclusively

Correct Answer: Chinese hamster ovary (CHO) cells

Q19. Which biomarker would be most relevant as a companion diagnostic for prescribing pembrolizumab in certain cancers?

• Serum creatinine level
• PD-L1 tumor expression level assessed by immunohistochemistry
• HER2 amplification by FISH
• EGFR T790M mutation only

Correct Answer: PD-L1 tumor expression level assessed by immunohistochemistry

Q20. Which pharmacokinetic elimination pathway predominates for therapeutic monoclonal antibodies?

• Renal glomerular filtration of intact antibody due to small size
• Proteolytic catabolism in reticuloendothelial and lysosomal pathways following cellular uptake
• Extensive metabolism by CYP3A4 in the liver
• Rapid exhalation via lungs

Correct Answer: Proteolytic catabolism in reticuloendothelial and lysosomal pathways following cellular uptake

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