KENILWORTH (NJ) (dpa-AFX) - Drug major Merck & Co., Inc. (MRK) announced
Friday that the European Medicines Agency's Committee for Medicinal Products for
Human Use or CHMP adopted a positive opinion recommending approval of its
anti-PD-1 therapy KEYTRUDA, in combination with platinum-containing
chemotherapy.

The recommendation is for the combination as neoadjuvant treatment, then
continued as a monotherapy as adjuvant treatment, for the treatment of
resectable non-small cell lung cancer or NSCLC at high risk of recurrence in
adults.

The CHMP's recommendation will now be reviewed by the European Commission for
marketing authorization in the European Union. A final decision is expected in
the first half of 2024.

The positive opinion was based on positive overall survival and event-free
survival results from the Phase 3 KEYNOTE-671 trial. In this, neoadjuvant
KEYTRUDA plus chemotherapy followed by adjuvant KEYTRUDA as a single agent after
surgical resection demonstrated statistically significant and clinically
meaningful improvements in the study's dual primary endpoints, versus
neoadjuvant placebo plus chemotherapy followed by adjuvant placebo in these
patients.

Marjorie Green, senior vice president and head of oncology, global clinical
development, Merck Research Laboratories, said, 'The CHMP's positive opinion
puts us another step closer to helping certain patients in Europe with earlier
stages of non-small cell lung cancer, regardless of PD-L1 expression. We look
forward to the European Commission's decision, as we continue to build on the
legacy of KEYTRUDA in certain types of lung cancer and pursue meaningful
advances that may help extend the lives of patients.'

In October 2023, KEYTRUDA was approved in the U.S. for the treatment of patients
with resectable NSCLC in combination with platinum-containing chemotherapy as
neoadjuvant treatment, and then continued as a single agent as adjuvant
treatment after surgery.

Earlier this week, the U.S. Food and Drug Administration accepted for priority
review a new supplemental Biologics License Application or sBLA seeking approval
for KEYTRUDA (pembrolizumab) in combination with standard of care chemotherapy
(carboplatin and paclitaxel). This will be followed by KEYTRUDA as a single
agent for the treatment of patients or primary advanced or recurrent Endometrial
Carcinoma.

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