Table 4.

Clinical efficacy summary by individual patient

Cohort no.*Hormone receptor statusHER/2-neu byDisease typeLesion site(s)Time to progression (wk)Best response
IHCFISH
1ER+/PR−2+PositiveBreastChest wall, lymph nodes, skin19.3PD
1NA1+NAColorectalLung12.9PD
1ER+/PR+1+NAOvarianLiver, pleura, peritoneum12.3PD
1NA1+NAOvarianChest wall, lymph nodes18.3SD
1NA2+NegativeOvarianLymph nodes, lung12.1PD
2ER−/PR+3+NABreastLung11.1PD
2NA1+PositiveColorectalLiver, spleen, lymph nodes, peritoneum8.1PD
2NA1+NAColorectalLiver, lung8.0PD
2NA1+NegativeOvarianLung, mesentery15.7SD
2ER−/PR−3+PositiveBreastBone, liver16.7SD
3ER+/PR+3+PositiveBreastLung3.9PD
3ER+/PR+3+NABreastBone, lymph nodes, lung, chest wall12.7PD
3ER−/PR−3+NABreastBreast, liver, bone16.9SD
3ER−/PR−3+NABreastBreast26.0SD
3ER−/PR−3+NABreastBreast, bone, lymph nodes8.0PD
3ER−/PR+2+NABreastBone, uterus, chest wall71.9,SD
3ER−/PR−3+PositiveBreastNA§49.4SD
3ER+/PR+3+NABreastBreast, liver8.1PD

Abbreviations: IHC, immunohistochemistry; FISH, fluorescent in situ hybridization; ER, estrogen receptor; PR, progesterone receptor; PD, progressive disease; SD, stable disease; NA, not available.

  • *Cohort 1: 10 μg/mL BA7072 antigen concentration; fresh lapuleucel-T ×1, cryopreserved lapuleucel-T ×2. Cohort 2: 40 μg/mL BA7072 antigen concentration; fresh lapuleucel-T ×1, cryopreserved lapuleucel-T ×2. Cohort 3: 40 μg/mL BA7072 antigen concentration; cryopreserved lapuleucel-T ×3.

  • Patient censored; patient reached the end of the follow-up period without developing disease progression.

  • Patient was re-treated at approximately 1 y.

  • §Patient had prior surgical resection of sternal and lung metastases.