3 ms·

"Previous data from the trial reported that 107 participants received the mRNA vaccine and Keytruda treatment, while the remaining 50 only received Keytruda. At

by zaptrem 8mo ago

"Previous data from the trial reported that 107 participants received the mRNA vaccine and Keytruda treatment, while the remaining 50 only received Keytruda. At the two-year follow-up, 24 of the 107 (22 percent) who got the experimental vaccine and Keytruda had recurrence or death, while 20 of 50 (40 percent) treated with just Keytruda had recurrence or death, indicating a 44 percent risk reduction" Statistically, if those in the control group had gotten the treatment, then in expectation 9 of those people wouldn't have had their cancer return or died. It must be exciting to run these sorts of trials with super promising drugs, but also a little bittersweet/dark.

readthenotes1 8mo ago
40% recurrence seems insanely high after just 2 years. It makes me wonder what the selection criteria for candidates were
- moioci 8mo ago
  from clinicaltrials.gov: Eligibility Criteria Key Inclusion Criteria: Resectable cutaneous melanoma metastatic to a lymph node and at high risk of recurrence Complete resection within 13 weeks prior to the first dose of pembrolizumab Disease free at study entry (after surgery) with no loco-regional relapse or distant metastasis and no clinical evidence of brain metastases Has an formalin fixed paraffin embedded (FFPE) tumor sample available suitable for sequencing Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 Normal organ and marrow function reported at screening Key Exclusion Criteria: Prior malignancy, unless no evidence of that disease for at least 5 years prior to study entry Prior systemic anti-cancer treatment (except surgery and interferon for thick primary melanomas. Radiotherapy after lymph node dissection is permitted) Live vaccine within 30 days prior to the first dose of pembrolizumab Transfusion of blood or administration of colony stimulating factors within 2 weeks of the screening blood sample Active autoimmune disease Immunodeficiency, systemic steroid therapy, or any other immunosuppressive therapy within 7 days prior to the first dose of pembrolizumab Solid organ or allogeneic bone marrow transplant Pneumonitis or a history of (noninfectious) pneumonitis that required steroids Prior interstitial lung disease Clinically significant heart failure Known history of human immunodeficiency virus (HIV) Known active hepatitis B or C Active infection requiring treatment Ages Eligible for Study 18 Years and older (Adult, Older Adult ) Sexes Eligible for Study All Accepts Healthy Volunteers No
Neywiny 8mo ago
You make a very good point. But the other side of it is that sometimes it goes poorly. The vaccine could have some previously unknown bad reaction with the Keytruda and the numbers get 44% worse instead. In this case it would be better to be in the vaccine group, but that's not guaranteed.
46493168 8mo ago
There are affordances for "this works so well and has so few side effects that we are ethically bound to give the control group the drug too." This happened with AZT for HIV.

by zaptrem 8mo ago

readthenotes1 8mo ago

40% recurrence seems insanely high after just 2 years. It makes me wonder what the selection criteria for candidates were

moioci 8mo ago
from clinicaltrials.gov: Eligibility Criteria Key Inclusion Criteria: Resectable cutaneous melanoma metastatic to a lymph node and at high risk of recurrence Complete resection within 13 weeks prior to the first dose of pembrolizumab Disease free at study entry (after surgery) with no loco-regional relapse or distant metastasis and no clinical evidence of brain metastases Has an formalin fixed paraffin embedded (FFPE) tumor sample available suitable for sequencing Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 Normal organ and marrow function reported at screening Key Exclusion Criteria: Prior malignancy, unless no evidence of that disease for at least 5 years prior to study entry Prior systemic anti-cancer treatment (except surgery and interferon for thick primary melanomas. Radiotherapy after lymph node dissection is permitted) Live vaccine within 30 days prior to the first dose of pembrolizumab Transfusion of blood or administration of colony stimulating factors within 2 weeks of the screening blood sample Active autoimmune disease Immunodeficiency, systemic steroid therapy, or any other immunosuppressive therapy within 7 days prior to the first dose of pembrolizumab Solid organ or allogeneic bone marrow transplant Pneumonitis or a history of (noninfectious) pneumonitis that required steroids Prior interstitial lung disease Clinically significant heart failure Known history of human immunodeficiency virus (HIV) Known active hepatitis B or C Active infection requiring treatment Ages Eligible for Study 18 Years and older (Adult, Older Adult ) Sexes Eligible for Study All Accepts Healthy Volunteers No

Neywiny 8mo ago

You make a very good point. But the other side of it is that sometimes it goes poorly. The vaccine could have some previously unknown bad reaction with the Keytruda and the numbers get 44% worse instead. In this case it would be better to be in the vaccine group, but that's not guaranteed.

46493168 8mo ago

There are affordances for "this works so well and has so few side effects that we are ethically bound to give the control group the drug too." This happened with AZT for HIV.