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On-Demand e-Posters Display

160P - Pembrolizumab re-challenge in patients with relapsed non-small cell lung cancer (NSCLC): a preliminary report of the REPLAY phase II trial - cohort I


09 Dec 2021


On-Demand e-Posters Display


Santiago Ponce Aix


Annals of Oncology (2021) 32 (suppl_7): S1428-S1457. 10.1016/annonc/annonc787


S. Ponce Aix1, E. Carcereny Costa2, J. Bosch-Barrera3, E. Felip Font4, M. Guirado5, J. Coves Sarto6, M. Majem Tarruella7, O.J. Juan Vidal8, E. Dalmau Portulas9, P. Diz10, A.L.O. Ortega Granados11, M. Domine Gomez12, A. Blasco Cordellat13, J. Mosquera Martinez14, M.A. Sala Gonzalez15, M. Dorta16, V. Calvo de Juan17, J. Zugazagoitia18, A.B. Enguita18, L. Paz-Ares19

Author affiliations

  • 1 Hospital 12 de Octubre, 28041 - Madrid/ES
  • 2 Catalan Institute of Oncology (ICO Badalona), Hospital Germans Trias i Pujol. B-ARGO Group, 8916 - Badalona/ES
  • 3 ICO - Institut Català d'Oncologia Girona (Hospital Universitari Josep Trueta Hospital Universitari Josep Trueta), 17007 - Girona/ES
  • 4 Vall d'Hebron University Hospital, 8035 - Barcelona/ES
  • 5 Hospital General Universitario de Elche, 3203 - Elche/ES
  • 6 Hospital Son Llatzer, 7198 - Palma de Mallorca/ES
  • 7 Hospital de la Santa Creu i Sant Pau, 8041 - Barcelona/ES
  • 8 Hospital Universitari i Politècnic La Fe, 46026 - Valencia/ES
  • 9 Hospital de Sabadell Corporacis Parc Tauli, 8208 - Sabadell/ES
  • 10 Complejo Asistencial Universitario de León - Hospital de León, 24071 - León/ES
  • 11 Hospital Universitario de Jaén, 23007 - Jaén/ES
  • 12 University Hospital "Fundacion Jimenez Diaz", 28040 - Madrid/ES
  • 13 Hospital General Universitario Valencia, 46014 - Valencia/ES
  • 14 CHUAC - Complexo Hospitalario Universitario A Coruña, 15006 - A Coruña/ES
  • 15 Hospital de Basurto, 48013 - Bilbao/ES
  • 16 Clinica Universidad de Navarra, 31008 - Pamplona/ES
  • 17 University Hospital Puerta de Hierro Majadahonda, 28222 - Majadahonda/ES
  • 18 Hospital Universitario 12 de Octubre, 28041 - Madrid/ES
  • 19 Universidad Complutense & CiberOnc, 28041 - Madrid/ES

Abstract 160P


Current front-line treatment for NSCLC includes PD1/PDL1 checkpoint inhibitors (CPI) alone or in combination with chemotherapy. Second line treatment approach is an unmet need, mainly limited to Docetaxel, and the utility of CPI is an open question. Here we report preliminary data of cohort 1 of the REPLAY trial that assess the efficacy of pembrolizumab (pembro) re-challenge.


REPLAY is an open label phase II multicenter exploratory study. Cohort 1 eligible patients had confirmed NCSLC (PDL1 ≥ 1%) who progressed after a line of treatment containing a CPI with documented benefit (SD, PR, CR) for at least 16 w and progression within 12 w of last cycle. Patients must have received then, previously to be enrolled, at least four courses of chemotherapy without progression. ECOG 0-1, adequate organ function and no G3-4 IrAEs were allowed. Patients received pembro 200 mg iv q3w until disease progression or toxicity up to 2 y. Primary endpoint was to evaluate ORR (RECIST 1.1), and secondary objectives included PFS, OS, safety and biomarker discovery.


55 patients were treated, including male 40 pts (72.7%), with median age 63.7 y, ECOG I (70.9%) and non-squamous histology 33 pts (60%). Forty-three pts (78.2%) had received > 3 treatment lines. An objective partial response was observed in 1 pt (1.9%) and stable disease observed in 21 pts (38.9%). Median number of pembro cycles were 5,3. 28 pts (50.9%) developed TRAEs: 14 pts (25.5%) G1, 11 pts (20%) G2 and 3 pts (5.5%) G3. Most frequent AEs were fatigue (14.5%), diarrhea (12.7%), pruritus (10.9%) and arthralgia (5.5%). No treatment-related deaths were reported. With a median follow-up of 7.6 m (0.3-27 m) median PFS was 1.6 m (IC95% 1.3 – 1.9 m), PFS at 6 m 23.6% and 7.3% at 12 m. OS was 8.3 m (IC95% 5.1 - 11.5 m), OS at 6 m 59.1% and at 12 m 35.2%.


Pembro re-challenge is a feasible and well tolerated strategy with non-overwhelming but definitive activity in a relevant proportion of patients (one PR, 24% PFS at 6 months) in this late treatment line setting. A comprehensive predictive biomarker program is ongoing.

Clinical trial identification


Legal entity responsible for the study

Spanish Lung Cancer Group (SLCG).




All authors have declared no conflicts of interest.

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