Retifanlimab is an investigational PD-1/PD-L1 inhibitor being studied in a phase II trial for advanced or metastatic Merkel cell carcinoma. As of January 2020, 27 patients had received retifanlimab, including 22 chemotherapy-naïve patients. Of the 18 chemotherapy-naïve patients who had at least one tumor assessment, 10 (56%) responded to treatment, including 2 with a complete response and 8 with a partial response. Retifanlimab demonstrated an acceptable safety profile, with the most common treatment-related adverse events being asthenia and pruritus. The initial results suggest promising activity and safety of retifanlimab for advanced or metastatic Merkel cell

1. 1/2
July 9, 2021
POD1UM-201: A phase II study of retifanlimab
(INCMGA00012) in advanced or metastatic Merkel cell car
telegra.ph/POD1UM-201-A-phase-II-study-of-retifanlimab-INCMGA00012-in-advanced-or-metastatic-Merkel-cell-car-
07-09
incmga00012
POD1UM-201 (incmga00012) Results at ESMO 2020
Abstract No : Abstract #1089P
Indication : Merkel cell carcinoma
Intervention : Retifanlimab
Company : Macrogenics
Technology : PD-1/PD-L1 inhibitor
Results of incmga00012:
As of January 8, 2020, 27 pts with MCC had received retifanlimab 500 mg IV Q4W (22
chemo-naïve, 5 refractories, all stage IV). Of the 22 chemo-naïve pts enrolled, 18 have had ≥1
on-study tumor assessment or discontinued. There are 10 (56%) responders (investigator-

2. 2/2
assessed) with 2 (11%) complete responses and 8 (44%) partial responses. Of these, 6 are
confirmed and 4 are unconfirmed ongoing responses.
Three pts (17%) have stable disease. Among all treated pts (n=27), 16 (59%) had a treatment-
emergent adverse event (TEAE); 6 (22%) were ≥Grade 3, 11 (41%) had a treatment-related
TEAE (TRAE), 3 (11%) of which were ≥Grade 3. The most common TRAEs were asthenia and
pruritus (n=3 each). Seven (26%) had a TEAE of special interest (the only immune-related
AE occurring in >1 pt was hypothyroidism [n=2]). Two pts (7%) discontinued treatment due
to TEAEs (radiculopathy and polyarthritis). No fatal TEAEs have been reported
Conclusion of incmga00012:-
Initial results demonstrate promising activity and safety of retifanlimab in pts with advanced
or metastatic chemo-naïve MCC. Updated results from a preplanned analysis for futility will
be presented at the meeting.