European Commission Approves Two New Regimens of Merck’s KEYTRUDA (pembrolizumab) as First-Line Treatment for Metastatic or Unresectable Recurrent…

By daniellenierenberg

This disease is especially debilitating since it can be highly visible and affect a patients appearance and their daily functions, such as eating and speaking, said Professor Kevin Harrington, investigator for KEYNOTE-048, professor of biological cancer therapies at The Institute of Cancer Research, London, and consultant clinical oncologist at The Royal Marsden NHS Foundation Trust. Considering the great need for new treatment options, we are encouraged by todays KEYTRUDA approval in Europe, which will allow certain patients to be treated with immunotherapy earlier in the course of their treatment.

This approval allows marketing of the KEYTRUDA monotherapy and combination regimen in all 28 EU member states plus Iceland, Lichtenstein and Norway.

KEYTRUDA is now the first anti-PD-1 treatment option in the first-line setting for metastatic or unresectable recurrent head and neck cancer, a disease that has been treated the same way in the EU for more than a decade, said Dr. Jonathan Cheng, vice president, clinical research, Merck Research Laboratories. The European Commission approval underscores our commitment to transforming the way cancer is treated around the world.

Data Supporting the European Approval

This approval is based on data from the Phase 3 KEYNOTE-048 trial, a multi-center, randomized, open-label, active-controlled trial conducted in 882 patients with histologically confirmed metastatic or recurrent HNSCC of the oral cavity, pharynx or larynx, who had not previously received systemic therapy for recurrent or metastatic disease and who were considered incurable by local therapies. Randomization was stratified by tumor PD-L1 expression (Tumor Proportion Score [TPS] 50% or <50%), HPV status (positive or negative), and ECOG Performance Status (PS) (0 vs. 1). The dual primary endpoints were OS and progression-free survival (PFS). Patients were randomized 1:1:1 to one of the following treatment arms:

Treatment with KEYTRUDA continued until RECIST v1.1-defined progression of disease as determined by the investigator, unacceptable toxicity or a maximum of 24 months.

Efficacy Results for KEYTRUDA as Monotherapy in KEYNOTE-048 with PD-L1 Expression(CPS 1)

Endpoint

KEYTRUDA

n=257

Standard

Treatment*

n=255

OS

Number (%) of patients with event

197 (77%)

229 (90%)

Median in months (95% CI)

12.3 (10.8, 14.3)

10.3 (9.0, 11.5)

Hazard ratio (95% CI)

0.74 (0.61, 0.90)

p-Value

0.00133

PFS

Number (%) of patients with event

228 (89%)

237 (93%)

Median in months (95% CI)

3.2 (2.2, 3.4)

5.0 (4.8, 6.0)

Hazard ratio (95% CI)

1.13 (0.94, 1.36)

p-Value

0.89580

ORR

Objective response rate (95% CI)

19.1% (14.5, 24.4)

35% (29.1, 41.1)

Complete response

5%

3%

Partial response

14%

32%

p-Value

1.0000

Duration of Response

Median in months (range)

23.4 (1.5+, 43.0+)

4.5 (1.2+, 38.7+)

% with duration 6 months

81%

36%

*

Cetuximab, platinum, and 5-FU

Based on the stratified Cox proportional hazard model

Based on stratified log-rank test

Response: Best objective response as confirmed complete response or partial response

Based on Miettinen and Nurminen method stratified by ECOG (0 vs. 1), HPV status (positive vs. negative) and PD-L1 status (strongly positive vs. not strongly positive)

Efficacy Results for KEYTRUDA plus Chemotherapy in KEYNOTE-048 with PD-L1 Expression(CPS 1)

Endpoint

KEYTRUDA +

Platinum Chemotherapy +

5-FU

n=242

Standard

Treatment*

n=235

OS

Number (%) of patients with event

177 (73%)

213 (91%)

Median in months (95% CI)

13.6 (10.7, 15.5)

10.4 (9.1, 11.7)

Hazard ratio (95% CI)

0.65 (0.53, 0.80)

p-Value

0.00002

PFS

Number (%) of patients with event

212 (88%)

221 (94%)

Median in months (95% CI)

5.1 (4.7, 6.2)

5.0 (4.8, 6.0)

Hazard ratio (95% CI)

0.84 (0.69, 1.02)

p-Value

0.03697

ORR

Objective response rate (95% CI)

36% (30.3, 42.8)

36% (29.6, 42.2)

Complete response

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European Commission Approves Two New Regimens of Merck's KEYTRUDA (pembrolizumab) as First-Line Treatment for Metastatic or Unresectable Recurrent...

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