SECOND LINE IS A
SECOND CHANCE
5 years of OS data in 2L mNSCLC1,2
In the primary analysis for CM 057 and CM 017, the median OS was 12.2 months (95% CI: 9.7–15.0) with OPDIVO vs 9.4 months (95% CI: 8.0–10.7) with docetaxel (HR=0.73 [95% CI: 0.60–0.89]; P=0.0015), and 9.2 months (95% CI: 7.3–13.3) with OPDIVO vs 6.0 months (95% CI: 5.1–7.3) with docetaxel (HR=0.59 [95% CI: 0.44–0.79]; P=0.0002), respectively.
In the primary analysis for CM 057 and CM 017, the median OS was 12.2 months (95% CI: 9.7–15.0) with OPDIVO vs 9.4 months (95% CI: 8.0–10.7) with docetaxel (HR=0.73 [95% CI: 0.60–0.89]; P=0.0015), and 9.2 months (95% CI: 7.3–13.3) with OPDIVO vs 6.0 months (95% CI: 5.1–7.3) with docetaxel (HR=0.59 [95% CI: 0.44–0.79]; P=0.0002), respectively.
In a pooled analysis of CM 057 and CM 017, the median OS was 11.1 months (95% CI: 9.2–13.1) with OPDIVO vs 8.1 months (95% CI: 7.2–9.2) with docetaxel (HR=0.68, 95% CI: 0.59–0.78);
the landmark 5-year OS rate with OPDIVO was 13.4% vs 2.6% with docetaxel.1,2
*vs docetaxel.2
In a pooled analysis of CM 057 and CM 017, the
median OS was 11.1 months (95% CI: 9.2–13.1)
with OPDIVO vs 8.1 months (95% CI: 7.2–9.2) with
docetaxel (HR=0.68, 95% CI: 0.59–0.78);
the landmark 5-year OS rate with
OPDIVO was 13.4% vs 2.6% with docetaxel.1,2
*vs docetaxel.2
Scroll to see primary and follow-up data below
In the Initial Analysis:
In previously treated non-squamous and squamous mNSCLC
OPDIVO: The only I-O therapy to achieve superior OS vs chemotherapy* in two
phase 3 studies designed to include PD-L1 expressors and non-expressors1,2
Both trials stopped early due
to superior OS3,4
More patients treated in
2L mNSCLC than
any other I-O therapy1,5
Non-Squamous (NSQ)1
- OPDIVO ORR was 19% (4 CRs, 95% CI: 15–24) vs 12%
with docetaxel (1 CR, 95% CI: 9–17); P=0.02 - mPFS was 2.3 months with OPDIVO vs 4.2 months with
docetaxel; HR=0.92 (95% CI: 0.77–1.11); P=0.39
Squamous (SQ)1
- OPDIVO ORR was 20% (1 CR, 95% CI: 14–28) vs 9%
with docetaxel (0 CRs, 95% CI: 5–15); P=0.0083 - mPFS was 3.5 months with OPDIVO vs 2.8 months with
docetaxel; HR=0.62 (95% CI: 0.47–0.81); P=0.0004
Select Important Safety Information
Serious Adverse Reactions
- In Checkmate 017 and 057, serious adverse reactions occurred in 46% of patients receiving OPDIVO (n=418).
The most frequent serious adverse reactions reported in ≥2% of patients receiving OPDIVO were pneumonia, pulmonary embolism, dyspnea, pyrexia, pleural effusion, pneumonitis, and respiratory failure. In Checkmate 057, fatal adverse reactions occurred; these included events of infection (7 patients, including one case of Pneumocystis jirovecii pneumonia), pulmonary embolism (4 patients), and limbic encephalitis (1 patient).
Common Adverse Reactions
- In Checkmate 017 and 057, the most common adverse reactions (≥20%) in patients receiving OPDIVO (n=418) were fatigue, musculoskeletal pain, cough, dyspnea, and decreased appetite.
*vs docetaxel.1
†Results were based on the pre-specified interim analysis. Minimum follow-up of 11 months for Checkmate 017 and 13.2 months for Checkmate 057.1,6,7
In the Extended Follow-Up at
5 Years:
In a pooled analysis of two
phase 3 trials
OPDIVO showed long-term 5-year OS in non-squamous and squamous mNSCLC2*
In a pooled analysis of two phase 3 trials
OPDIVO showed long-term 5-year OS in non-squamous and squamous mNSCLC2*
Pooled 5-year extended overall survival analysis2‡§
*vs docetaxel.2
‡A pooled analysis of CM 017 and CM 057. CM 017 and CM 057 were registrational, randomized, phase 3 studies of OPDIVO vs
docetaxel in patients with 2L SQ or 2L/3L NSQ mNSCLC, respectively.2
§The pooled patient population (n=427) for OPDIVO consisted of 292 patients with NSQ and 135 with SQ histology. The pooled
patient population (n=427) for docetaxel consisted of 290 patients with NSQ and 137 with SQ histology.1,2
Longest follow-up of two phase 3 trials in 2L mNSCLC regardless of PD-L1 expression2
In the Extended Follow-Up at
5 Years:
In a pooled analysis of two phase 3 trials that evaluated non-squamous and squamous mNSCLC
Among OPDIVO responders,|| mOS was not reached at 5 years2,8,9||
CM 057 and CM 017
pooled ORR2¶#**
Pooled 5-year extended
overall survival analysis in complete and partial responders2,8,9||¶#
53% of OPDIVO responders||
were alive at 5 years8,9¶
||OS was calculated from the time of response (CR/PR) for each responder.8
¶A pooled analysis of CM 017 and CM 057. CM 017 and CM 057 were registrational, randomized, phase 3 studies of OPDIVO vs docetaxel in patients with 2L SQ or 2L/3L NSQ mNSCLC, respectively. The pooled patient population (n=427) for OPDIVO consisted of 292 patients with NSQ and 135 with SQ histology. The pooled patient population (n=427) for docetaxel consisted of 290 patients with NSQ and 137 with SQ histology.8
#Since the initial analysis of the CM 057 study, 1 patient's response changed from SD to PR, and 1 from PR to CR.2
**In CM 057, the ORR was 19% (56/292; 4 CRs) (95% CI: 15–24) with OPDIVO vs 12% (36/290;
1 CR) (95% CI: 9–17) with docetaxel; P=0.02. The median duration of response was 17 months in the OPDIVO arm (95% CI: 8.4–NR) and 6 months in the docetaxel arm (95% CI: 4.4–7.0).1 In CM 017, the ORR was 20% (27/135; 1 CR) (95% CI: 14–28) with OPDIVO vs 9% (12/137; 0 CRs) (95% CI: 5–15) with docetaxel; P=0.0083.1 The median duration of response was NR months in the OPDIVO arm (95% CI: 9.8–NR) and 8.4 months in the docetaxel arm (95% CI: 3.6–10.8).1
Select Safety Profile:
For previously treated mNSCLC
OPDIVO selected safety profile1,2
Adverse reactions occurring in ≥10% (all grades) of patients treated with OPDIVO
and at a higher incidence than docetaxel (between-arm difference of ≥5% [all grades]
or ≥2% [Grades 3-4]) in Checkmate 017 and 0571
OPDIVO (n=418) | Docetaxel (n=397) | |||
---|---|---|---|---|
Adverse reactions | All grades | Grades 3-4 | All grades | Grades 3-4 |
Respiratory, thoracic, and mediastinal disorders, % Cough | 31 | 0.7 | 24 | 0 |
Metabolism and Decreased appetite | 28 | 1.4 | 23 | 1.5 |
Skin and subcutaneous tissue disorders, % Pruritus | 10 | 0.2 | 2.0 | 0 |
OPDIVO (n=418) | Docetaxel (n=397) | |
---|---|---|
Adverse reactions | All grades | All grades |
Respiratory, thoracic, Cough | 31 | 24 |
Metabolism and nutrition disorders, % Decreased | 28 | 23 |
Skin and subcutaneous tissue disorders, % Pruritus | 10 | 2.0 |
OPDIVO (n=418) | Docetaxel (n=397) | |
---|---|---|
Adverse reactions | Grades 3-4 | Grades 3-4 |
Respiratory, thoracic, Cough | 0.7 | 0 |
Metabolism and nutrition disorders, % Decreased | 1.4 | 1.5 |
Skin and subcutaneous tissue disorders, % Pruritus | 0.2 | 0 |
- The safety profile of OPDIVO was evaluated across squamous and non-squamous histologies in
patients with previously treated mNSCLC - The most common adverse reactions (reported in ≥20% of patients) were fatigue, musculoskeletal
pain, cough, dyspnea, and decreased appetite - Serious adverse reactions occurred in 46% of patients receiving OPDIVO
- The most frequent serious adverse reactions reported in at least 2% of patients receiving OPDIVO were
pneumonia, pulmonary embolism, dyspnea, pyrexia, pleural effusion, pneumonitis, and respiratory failure
- The most frequent serious adverse reactions reported in at least 2% of patients receiving OPDIVO were
- OPDIVO was discontinued due to adverse reactions in 11% of patients
- 28% of patients receiving OPDIVO had a drug delay for an adverse reaction
- With 5 years minimum follow-up, no new safety signals were identified for OPDIVO2
2L=second-line; 3L=third-line; CI=confidence interval; CM=Checkmate; CR=complete response; DOR=duration of response;
HR=hazard ratio;
I-O=immuno-oncology; mNSCLC=metastatic non-small cell lung cancer; mOS=median OS;
mos=months; mPFS=median progression-free survival; NR=not reached; ORR=overall response rate; OS=overall survival;
PD-L1=programmed death-ligand 1; PR=partial response.