Real-world efficacy of the first line therapy with prolgolimab in patients with metastatic melanoma: interim results of the FORA (FOrteca Real practice Assessment) observational study

Kristina V. Orlova; Орлова Кристина Вячеславовна; Mikhail Yu. Fedyanin; Федянин Михаил Юрьевич; Konstantin E. Simanenkov; Симаненков Константин Эдуардович; Aleksandr S. Dergunov; Дергунов Александр Сергеевич; Petr R. Goldshmidt; Гольдшмидт Петр Рудольфович; Aleksandra F. Saydullaeva; Сайдуллаева Александра Федоровна; Dary V. Bogacheva; Богачева Дарья Вячеславовна; Marina A. Yavorskaya; Яворская Марина Алексеевна; Artur Z. Azanov; Азанов Артур Закирчанович; Alexander A. Fedenko; Феденко Александр Александрович; Larisa V. Bolotina; Болотина Лариса Владимировна; Tatyana I. Deshkina; Дешкина Татьяна Игоревна; Kseniya G. Babina; Бабина Ксения Геннадьевна; Ekaterina A. Kuzevanova; Кузеванова Екатерина Андреевна; Liudmila G. Zhukova; Жукова Людмила Григорьевна; Polina S. Feoktistova; Феоктистова Полина Сергеевна; Natalya I. Polshina; Польшина Наталья Ивановна; Ekaterina V. Peganova; Пеганова Екатерина Вячеславовна; Valentina E. Shikina; Шикина Валентина Евгеньевна; Maksim M. Sobolev; Соболев Максим Михайлович; Oleg V. Mironov; Миронов Олег Вячеславович; Vera A. Vaschenko; Ващенко Вера Александровна; Mariya M. Ershova; Ершова Мария Максимовна; Agniya O. Mezhueva; Межуева Агния Олеговна; Svetlana A. Orlova; Орлова Светлана Александровна; Denis A. Tantsyrev; Танцырев Денис Анатольевич; Darya K. Taskina; Таскина Дарья Константиновна; Antonina A. Teterich; Тетерич Антонина Анатольевна; Elena V. Karabina; Карабина Елена Владимировна; Yuliya V. Kostalanova; Косталанова Юлия Владимировна; Marina V. Bogacheva; Богачева Марина Владимировна; Natalia V. Zhukova; Жукова Наталья Владимировна; Rashida V. Orlova; Орлова Рашида Вахидовна; Maksim V. Zinkevich; Зинькевич Максим Вячеславович; Aleksandr I. Kazmin; Казьмин Александр Иванович; Mikhail V. Volkonskiy; Волконский Михаил Викторович; Liya M. Voronkova; Воронкова Лия Михайловна; Anastasiya S. Karpova; Карпова Анастасия Сергеевна; Mikhail L. Maleyko; Малейко Михаил Леонидович; Mariya N. Gorshenina; Горшенина Мария Николаевна; Elena I. Kryuchkova; Крючкова Елена Ивановна; Fedor V. Moiseenko; Моисеенко Федор Владимирович; Yuliya I. Murzina; Мурзина Юлия Ивановна; Shamil I. Musin; Мусин Шамиль Исмагилович; Andrey N. Ogloblin; Оглоблин Андрей Николаевич; Mariya S. Perminova; Перминова Мария Сергеевна; Regina A. Dumbrava; Думбрава Регина Анатольевна; Sergey A. Emelyanov; Емельянов Сергей Анатольевич; Svetlana A. Protsenko; Проценко Светлана Анатольевна; Alexander V. Sultanbaev; Султанбаев Александр Валерьевич; Anna V. Tarasova; Тарасова Анна Владимировна; Elena B. Shakhnovich; Шахнович Елена Борисовна; Marina V. Demchenkova; Демченкова Марина Викторовна; Yuliya A. Lozovskaya; Лозовская Юлия Александровна; Khedi S. Musaeva; Мусаева Хеди Салмановна; Elena M. Pavlova; Павлова Елена Михайловна; Roman A. Skotnikov; Скотников Роман Александрович; Vera V. Chernova; Чернова Вера Васильевна; Angelina S. Chichkanova; Чичканова Ангелина Семеновна; Adina M. Akhmatova; Ахматова Адина Муссаевна; Marina A. Zafirova; Зафирова Марина Ахилесовна; Andrey A. Mischenko; Мищенко Андрей Андреевич; Elena N. Ovsienko; Овсиенко Елена Николаевна; Viktoriya A. Petrukhnenko; Петрухненко Виктория Александровна; Oksana A. Syusyukaylova; Сюсюкайлова Оксана Анатолевна; Yana A. Tyugina; Тюгина Яна Александровна; Elena A. Shumilkina; Шумилкина Елена Александровна; Daniil L. Stroyakovskiy; Строяковский Даниил Львович; Aleksandr N. Yurchenkov; Юрченков Александр Николаевич; Pavel L. Baldin; Балдин Павел Леонидович; Anastasiya S. Belova; Белова Анастасия Сергеевна; Olga V. Diduk; Дидук Ольга Викторовна; Elena A. Konovalova; Коновалова Елена Александровна; Lyudmila N. Lebedeva; Лебедева Людмила Николаевна; Yaroslav A. Li; Ли Ярослав Андреевич; Viktoriya V. Mashtapa; Маштапа Виктория Валерьевна; Yana A. Mironenkova; Мироненкова Яна Александровна; Kristina V. Narovenkova; Наровенкова Кристина Васильевна; Olga A. Pavlikova; Павликова Ольга Аркадьевна; Elvira L. Parsadanova; Парсаданова Эльвира Левоновна; Irina S. Pimonova; Пимонова Ирина Сергеевна; Anna A. Ruzhnikova; Ружникова Анна Алексеевна; Irina D. Sivunova; Сивунова Ирина Догувна; Ekaterina P. Soloveva; Соловьева Екатерина Петровна; Maksim I. Sosnin; Соснин Максим Игоревич; Toita Kh. Temirsultanova; Темирсултанова Тоита Хасановна; Makhabbat Zh. Tyulegenova; Тюлегенова Махаббат Жикписбаевна; Aleksandra V. Khodkevich; Ходкевич Александра Васильевна; Nadezhda R. Shakurova; Шакурова Надежда Ревгатовна; Sureya N. Efendieva; Эфендиева Сурея Наджуллаховна; Karine L. Avagimyan; Авагимян Каринэ Левоновна; Ekaterina P. Anokhina; Анохина Екатерина Павловна; Mariya I. Antoshkina; Антошкина Мария Ивановна; Stanislav M. Borzyanitsa; Борзяница Станислав Михайлович; Samir K. Dzhentemirov; Джентемиров Самир Кайтарбиевич; Marina V. Dmitrochenko; Дмитроченко Марина Владимировна; Alla V. Zheleznyak; Железняк Алла Викторовна; Yuliya V. Komoza; Комоза Юлия Валерьевна; Aleksandr S. Kopanev; Копанев Александр Сергеевич; Tatyana I. Kornienko; Корниенко Татьяна Ивановна; Margarita A. Krasilnikova; Красильникова Маргарита Андреевна; Darya A. Lukhmanova; Лухманова Дарья Александровна; Natalya S. Mazur; Мазур Наталья Сергеевна; Polina M. Markina; Маркина Полина Михайловна; Zhargal S. Mitapov; Митапов Жаргал Сергеевич; Svetlana N. Osodoeva; Осодоева Светлана Николаевна; Irina A. Prokopenko; Прокопенко Ирина Александровна; Irina M. Radyukova; Радюкова Ирина Михайловна; Madina S. Ramazanova; Рамазанова Мадина Султановна; Alfiya R. Safarova; Сафарова Альфия Риядовна; Mariya A. Safronova; Сафронова Мария Александровна; Khalimat M. Khabrieva; Хабриева Халимат Мухарбековна; Natalya S. Tsygankova; Цыганкова Наталья Сергеевна; Kseniya V. Chermakova; Чермакова Ксения Вадимовна; Tatyana A. Chirkova; Чиркова Татьяна Александровна; Igor V. Samoylenko; Самойленко Игорь Вячеславович; Valeria V. Nazarova; Назарова Валерия Витальевна; Angelina E. Akhmetyanova; Ахметьянова Ангелина Евгеньевна; Lev V. Demidov; Демидов Лев Вадимович

doi:10.26442/18151434.2022.4.202035

Real-world efficacy of the first line therapy with prolgolimab in patients with metastatic melanoma: interim results of the FORA (FOrteca Real practice Assessment) observational study

Authors: Orlova K.V.¹, Fedyanin M.Y.¹^,2^,3, Simanenkov K.E.⁴, Dergunov A.S.⁵, Goldshmidt P.R.⁶, Saydullaeva A.F.⁵, Bogacheva D.V.⁷, Yavorskaya M.A.⁸, Azanov A.Z.⁹, Fedenko A.A.¹⁰, Bolotina L.V.¹⁰, Deshkina T.I.¹⁰, Babina K.G.¹¹, Kuzevanova E.A.¹², Zhukova L.G.¹³, Feoktistova P.S.¹³, Polshina N.I.¹³, Peganova E.V.¹⁴, Shikina V.E.¹⁵, Sobolev M.M.¹⁶, Mironov O.V.¹⁷, Vaschenko V.A.¹⁸, Ershova M.M.¹⁹, Mezhueva A.O.², Orlova S.A.²⁰, Tantsyrev D.A.²¹, Taskina D.K.²², Teterich A.A.²³, Karabina E.V.²⁴, Kostalanova Y.V.²⁵, Bogacheva M.V.²⁶, Zhukova N.V.²⁷^,28, Orlova R.V.²⁸, Zinkevich M.V.²⁹, Kazmin A.I.⁷, Volkonskiy M.V.³⁰, Voronkova L.M.³¹, Karpova A.S.³², Maleyko M.L.³³, Gorshenina M.N.³⁴, Kryuchkova E.I.³⁵, Moiseenko F.V.³⁶, Murzina Y.I.³⁷, Musin S.I.³⁸, Ogloblin A.N.³⁹, Perminova M.S.⁹, Dumbrava R.A.⁴⁰, Emelyanov S.A.⁴¹, Protsenko S.A.⁴², Sultanbaev A.V.³⁸, Tarasova A.V.²⁵, Shakhnovich E.B.⁴³, Demchenkova M.V.⁴⁴, Lozovskaya Y.A.⁴⁵, Musaeva K.S.⁴⁶, Pavlova E.M.⁴⁷, Skotnikov R.A.²⁴, Chernova V.V.⁴⁸, Chichkanova A.S.⁴⁹, Akhmatova A.M.⁵⁰, Zafirova M.A.¹⁹, Mischenko A.A.⁴⁰, Ovsienko E.N.⁴¹, Petrukhnenko V.A.⁵¹, Syusyukaylova O.A.⁵², Tyugina Y.A.⁵³, Shumilkina E.A.²⁰, Stroyakovskiy D.L.³⁰, Yurchenkov A.N.³⁰, Baldin P.L.⁵⁴, Belova A.S.⁵⁵, Diduk O.V.⁵⁶, Konovalova E.A.⁵⁷, Lebedeva L.N.⁵⁸, Li Y.A.⁵⁹, Mashtapa V.V.⁴⁵, Mironenkova Y.A.⁴⁷, Narovenkova K.V.⁶⁰, Pavlikova O.A.³⁴, Parsadanova E.L.⁶¹, Pimonova I.S.⁶², Ruzhnikova A.A.⁵⁸, Sivunova I.D.⁶³, Soloveva E.P.⁵⁸, Sosnin M.I.⁶⁴, Temirsultanova T.K.⁴⁶, Tyulegenova M.Z.⁶⁵, Khodkevich A.V.⁶⁰, Shakurova N.R.⁶⁶, Efendieva S.N.⁶⁷, Avagimyan K.L.⁴⁵, Anokhina E.P.⁶⁸, Antoshkina M.I.⁶⁹, Borzyanitsa S.M.⁹, Dzhentemirov S.K.⁷⁰, Dmitrochenko M.V.³⁵, Zheleznyak A.V.⁴⁹, Komoza Y.V.⁶⁰, Kopanev A.S.⁷¹, Kornienko T.I.¹⁷, Krasilnikova M.A.⁹, Lukhmanova D.A.⁶⁸, Mazur N.S.¹⁹, Markina P.M.⁴⁹, Mitapov Z.S.⁷², Osodoeva S.N.⁷², Prokopenko I.A.⁴⁵, Radyukova I.M.⁷³, Ramazanova M.S.⁷¹, Safarova A.R.⁷⁴, Safronova M.A.³⁵, Khabrieva K.M.⁷⁵, Tsygankova N.S.³⁵, Chermakova K.V.⁴⁵, Chirkova T.A.⁷⁶, Samoylenko I.V.¹, Nazarova V.V.¹, Akhmetyanova A.E.¹, Demidov L.V.¹
Affiliations:
1. Blokhin National Medical Research Center of Oncology
2. Moscow Multidisciplinary Clinical Center “Kommunarka“
3. Pirogov National Medical and Surgical Center
4. Lipetsk Regional Oncological Dispensary
5. Tver Regional Clinical Oncological Dispensary
6. Rostov-on-Don Oncological Dispensary
7. Voronezh Regional Clinical Oncology Dispensary
8. Sochi Oncological Dispensary №2
9. Rappoport Kuzbass Clinical Oncological Dispensary
10. Hertsen Moscow Oncology Research Institute – branch of the National Medical Research Radiological Centre
11. Volgograd Regional Clinical Oncological Dispensary
12. Saratov Regional Clinical Oncological Dispensary
13. Loginov Moscow Clinical Scientific Center
14. Yaroslavl Clinical Oncology Hospital
15. Vladimirsky Moscow Regional Research Clinical Institute
16. City Clinical Oncology Hospital №1
17. Tambov Regional Oncological Clinical Dispensary
18. Kostroma Oncological Dispensary
19. Sverdlovsk Regional Oncological Dispensary
20. Cheboksary Republican Clinical Oncological Dispensary
21. Altai Regional Oncological Dispensary
22. Chelyabinsk Regional Clinical Center of Oncology and Nuclear Medicine
23. Belgorod Regional Oncological Dispensary
24. Tula Regional Clinical Oncological Dispensary
25. Samara Regional Clinical Oncology Dispensary
26. Vologda Regional Clinical Hospital №2
27. Saint Petersburg State University
28. Saint Petersburg City Clinical Oncology Dispensary
29. Leningrad Regional Clinical Oncology Dispensary
30. Moscow City Oncological Hospital №62
31. Vladikavkaz Republican Oncological Dispensary
32. Trans-Baikal Regional Oncological Dispensary
33. Shakhty Oncological Dispensary
34. Yoshkar-Ola Republican Oncological Dispensary
35. Smolensk Regional Oncological Clinical Dispensary
36. Saint Petersburg Clinical Scientific and Practical Center for Specialized Types of Medical Care (Oncology)
37. Birobidzhan Oncological Dispensary
38. Ufa Republican Clinical Oncology Center
39. Oryol Oncological Dispensary
40. Primorsky Regional Oncological Dispensary
41. Primushko Republican Clinical Oncological Dispensary
42. Petrov National Medical Research Center of Oncology
43. Korolyov City Hospital
44. Irkutsk Regional Oncological Dispensary
45. Ostroverkhov Kursk Cancer Research and Clinical Center
46. Oncology Center “AiMed”
47. Vologda Regional Oncological Dispensary
48. Ryazan Regional Clinical Oncological Dispensary
49. Nizhny Novgorod Regional Clinical Oncology Center
50. Nalchik Oncological Dispensary
51. Komsomolsk-on-Amur Oncological Dispensary
52. Ashkhamaf Adygei Republican Clinical Oncology Center
53. Ivanovo Regional Oncological Dispensary
54. Naberezhnye Chelny Oncological Dispensary – branch of the Republican Clinical Oncological Dispensary
55. Novgorod Regional Clinical Oncological Dispensary
56. Kryzhanovsky Krasnoyarsk Regional Clinical Oncology Dispensary
57. Murmansk Regional Oncological Dispensary
58. Arkhangelsk Clinical Oncology Dispensary
59. Clinic Lyadov
60. Bryansk Regional Oncological Dispensary
61. Sakhalin Regional Oncological Dispensary
62. Tsyb Medical Radiological Research Centre – branch of the National Medical Research Radiological Center
63. Kamchatka Regional Oncology Center
64. Krasnogorsk City Hospital №1
65. Orenburg Regional Clinical Oncology Dispensary
66. Tomsk Regional Oncological Dispensary
67. Makhachkala Republican Cancer Center
68. Ulyanovsk Regional Clinical Oncology Dispensary
69. Saransk Republican Oncological Dispensary
70. Stavropol Regional Clinical Oncology Center
71. Kirov Center of Oncology and Medical Radiology
72. Buryat Republican Clinical Oncological Dispensary
73. Omsk Clinical Oncological Dispensary
74. Almetyevsk branch of the Republican Clinical Oncological Dispensary
75. Republican Oncological Dispensary of the Republic of Ingushetia
76. Rappoport Novokuznetsk branch of the Kuzbass Clinical Oncological Dispensary
Issue: Vol 24, No 4 (2022)
Pages: 413-425
Section: CLINICAL ONCOLOGY
URL: https://journals.rcsi.science/1815-1434/article/view/132974
DOI: https://doi.org/10.26442/18151434.2022.4.202035
ID: 132974

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Abstract

Background. Novel agents – immune checkpoint inhibitors – fundamentally changed the prognosis for life in patients with metastatic and/or inoperable melanoma. The development, studies, and approval of a new original PD1 inhibitor in Russia in 2020 prompted the professional community to conduct a prospective observational study in the Russian Federation to assess the real-world efficacy and safety of prolgolimab, as real-world patients differ from the refined population in clinical trials.

Aim. To evaluate the real-world efficacy and safety of prolgolimab in patients with metastatic and/or inoperable melanoma.

Materials and methods. From October 2020 to October 2022, the study enrolled 700 patients with metastatic and/or inoperable melanoma receiving prolgolimab in real clinical settings in oncological institutions of various levels in the Russian Federation. The main inclusion criteria were: pathology-confirmed diagnosis of melanoma, metastatic and/or inoperable type, use of prolgolimab outside of clinical trials, and signed informed consent by the patient. Objective response rate (ORR) was considered the main criterion for evaluating the efficacy of therapy, and the safety criterion was the incidence of grade 3–4 adverse events. Statistical analysis was performed using the SPSS 20.0 software package.

Results. The ORR for patients with skin melanoma treated with prolgolimab in the first line therapy (n= 207/337) was 48.3% (n=100), the disease stabilization was reported in 30.4% (n=63), and progression in 21.3% (n=44) of patients. There were no significant differences in response to therapy between patients with/without BRAF mutation, although ORR was higher in patients with BRAF mutation: the ORR for patients with BRAF mutation was 57.9% (n=33), and for BRAF non-mutated patients, 44.4% (n=52; p=0.222). At a median follow-up of 5 months, the median PFS was 10 months (95% confidence interval 7.35–12.64). The incidence of grade 3–4 treatment-related adverse events according to CTCAE 5.0 was 2% (n=12), and 12% (n=82) for grade 1–2 adverse events.

Conclusion. The results confirm the high efficacy and satisfactory tolerability of prolgolimab in patients with metastatic and/or inoperable melanoma in real-world settings. There were no significant differences in ORR between patients with or without BRAF mutation.

Keywords

metastatic melanoma, prolgolimab, anti-PD1, prospective observational study, BRAF, FORA, skin melanoma

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About the authors

Kristina V. Orlova

Blokhin National Medical Research Center of Oncology

Author for correspondence.
Email: krisman03@gmail.com
ORCID iD: 0000-0002-0442-5917

Cand. Sci. (Med.)

Russian Federation, Moscow

Mikhail Yu. Fedyanin

Blokhin National Medical Research Center of Oncology; Moscow Multidisciplinary Clinical Center “Kommunarka“; Pirogov National Medical and Surgical Center

Email: krisman03@gmail.com
ORCID iD: 0000-0001-5615-7806

D. Sci. (Med.)

Russian Federation, Moscow; Moscow; Moscow

Konstantin E. Simanenkov

Lipetsk Regional Oncological Dispensary

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Real-world efficacy of the first line therapy with prolgolimab in patients with metastatic melanoma: interim results of the FORA (FOrteca Real practice Assessment) observational study

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