(Lung Cancer) Pembrolizumab Monotherapy: What the Study Reported

(Lung Cancer) Pembrolizumab Monotherapy: What the Study Reported

(Lung Cancer) Pembrolizumab Monotherapy: What the Study Reported

(Lung Cancer) Pembrolizumab Monotherapy: What the Study Reported

• September 9, 2019
• 2 min read

On July 11, 2019, Joshua M. Bauml published in the medical journal JAMA Oncology the results of a Phase II clinical trial evaluating the efficacy and safety of anti-PD-1 antibody Keytruda (pembrolizumab) monotherapy in non-small cell lung cancer patients with oligometastatic disease after local treatment.

This Phase II clinical trial enrolled non-small cell lung cancer patients with oligometastatic disease after local treatment (N=45). Patients received Keytruda 200mg monotherapy in 3-week cycles. The primary endpoint was progression-free survival, with oligometastatic sites defined as four or fewer.

The background for this trial was that in other clinical trials, oligometastatic non-small cell lung cancer patients who received first-line treatment showed significantly improved progression-free survival compared to those receiving supportive care. In recent years, immune checkpoint inhibitors have become the standard treatment for non-small cell lung cancer. Therefore, this trial was initiated to evaluate the usefulness of anti-PD-1 Keytruda in oligometastatic non-small cell lung cancer patients.

Patient characteristics were as follows:

Median age

64 years (46-82 years)

Sex

Male = 53% (N=24)

Female = 47% (N=21)

Performance status

ECOG score 0: 49% (N=22)

ECOG score 1: 51% (N=23)

Smoking history

Current smokers: 11% (N=5)

Former smokers: 78% (N=35)

Never smokers: 11% (N=5)

Histological classification

Adenocarcinoma: 76% (N=34)

Squamous cell carcinoma: 18% (N=8)

Other: 7% (N=3)

TNM classification T factor (tumor stage)

T1 = 42% (N=19)

T2 = 27% (N=12)

T3 = 7% (N=3)

T4 = 16% (N=7)

TNM classification N factor (lymph node metastasis)

N0 = 36% (N=16)

N1 = 18% (N=8)

N2 = 27% (N=13)

N3 = 9% (N=4)

Metastatic sites

Lung = 31% (N=14)

Brain = 36% (N=16)

Adrenal gland = 13% (N=6)

Bone = 11% (N=5)

Liver = 11% (N=5)

The trial results showed that for the primary endpoint, the median progression-free survival from the start of local treatment to disease progression was 19.1 months, a significant improvement over the historical benchmark of 6.6 months. The median progression-free survival from the start of Keytruda treatment to disease progression was 18.7 months. For secondary endpoints, the median overall survival was 41.6 months, with 12-month overall survival of 90.9% and 24-month overall survival of 90.9%.

Regarding safety, the most common adverse events were: pain 42% (19/45), fatigue 36% (N=16), skin-related adverse events 22% (N=10), dyspnea 18% (N=8), cough 16% (N=7), pruritus 6% (N=7). Grade 3-4 adverse events included: pain 2% (1 patient), dyspnea 2% (1 patient), nausea 2% (1 patient), Grade 3 pneumonitis 4% (N=2), and Grade 4 pneumonitis 2% (N=1).

Based on the Phase II clinical trial results, Joshua M. Bauml concluded that anti-PD-1 antibody Keytruda monotherapy showed significant improvement in oligometastatic non-small cell lung cancer patients after local treatment compared to existing clinical trial data.

Source: Pembrolizumab After Completion of Locally Ablative Therapy for Oligometastatic Non-Small Cell Lung Cancer A Phase 2 Trial (JAMA Oncol. 2019 July 11. doi: 10.1001/jamaoncol.2019.1449.)

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