Table 1.

Comparison of pembrolizumab/chemotherapy versus olaparib from a practical standpoint

Comparative aspect	Olaparib	Pembrolizumab/Chemotherapy
Clinical trial	OlympiAD	Keynote 355
Eligibility in mTNBC	gBRCA, sBRCA, gPALB2*	CPS ≥ 10
Response rate reported	60%	41%
Median duration of response	6.4 Months (IQR, 2.8 to 9.7) in the olaparib group compared to 7.1 months (IQR, 3.2 to 12.2) in the standard chemotherapy group	12.8 Months (95% CI 9.9–25.9) in pembrolizumab/chemotherapy group compared to 7.3 months (95% CI 5.5–15.4) in the chemotherapy group
Median time to onset of response	47 Days	Not reported
Median PFS	7.0 Months versus 4.2 months in the olaparib group compared to the standard-therapy group respectively (HR 0.58; 95% Cl 0.43–0.80; P < 0.001).	9.7 Months with pembrolizumab-chemotherapy compared to 5.6 months with placebo-chemotherapy respectively; HR 0.65, 95% CI 0.49–0.86; one-sided P = 0.0012 (co-primary objective met)
OS	No OS benefit in the ITT. OS of 22.6 months compared to 14.7 months if used in the 1st line setting (HR 0.55; 95% CI 0.33–0.95, P = 0.02)**	OS of 23.0 months compared to 16.1 months in the placebo-chemotherapy group (HR 0.73; 95% CI 0.55–0.95; P = 0.0093)
Contraindications	MDS/AML Pneumonitis	Active severe autoimmune disease
Possible adverse effects	Myelosuppression, nausea, vomiting, risk of MDS/AML, pneumonitis	Any autoimmune adverse events including but not limited to irreversible hypophysitis, adrenal insufficiency, thyroiditis, fatal cardiomyositis
Convenience	Oral therapy requiring monthly follow up to monitor	IV therapy every 3 weeks

^* Patients with HER2 negative MBC with gPALB2 or sBRCA1/2 mutations were found to benefit from treatment with olaparib according to TBCRC 048, a phase II trial of olaparib for MBC and homologous recombination-related gene mutations; ^** post hoc analysis. IQR: interquartile range; MDS: myelodysplastic syndrome; AML: acute myeloid leukemia; IV: intravenous