Online Class Notes (Ally)
As you all know, this is the close medical monitoring plan for 311 study in China that we have implemented since Dec 2022.
Let’s review the details first. There main aspects – PI engagement, support site, and real time safety data monitoring.
Let’s move on to discussing the enrollment status of this study in China. As of may 18th, we have screened 45 patients and 27 subjects. More 2nd line patients were enrolled in this study, also 17/45 patients were screen failure, the s.f. rate was 37.8%.
After our analysis, these are some reasons behind this number.
The main reason was objective examination, which accounted for 71% of screening failures.
The other reasons were medical judgement and IP unavailability.
If we look at the SF rate on the right side of this slide, we can see the rate decreased from 44% in 2022 to 29% in 2023. So actually, the rate has decreased significantly.
Let’s move on the patient status as of May 15th, 2023. Due to the delay of the EDC system, 23 out of 27 patients were recorded in the EDC system. From this data, we can see 9 patients are randomized to the Loca+R arm: 5 are on treatment, 1 is EOT and 3 are EOS. For the 14 patients on R-GemOx arm, 4 are on treatment. 9 are EOT and 1 is EOS.
On this slide, I want to show you the baseline characterstics of patients in the study. From this table, we can see that overall, the characteristics of Chinese patients versus global patients are similar, except for age, histology, and prior systematic therapy lines. As for age, the median age is a little bit younger than that of global patients. But from the aspect of histology, all of the 23 patients were DLBCL, and none were high-grade … As for the prior systematic therapy lines, the China was 2 versus 1 in global. The percentage of second line patients enrolled in China was still less than that in global.
As for the relapse and refractory patients, they are pretty similar in China and global.
On this slide, I will briefly introduce TEAEs of patients enrolled in China.
We continue to monitor the TEAEs of the patients in China and summarize the data every two weeks. If you see the last column of this data, it is the most recent data, as of may 15th. We can see from this data, these TEAEs are possibly related to the treatment.
I just want to remind everyone that the sample size is quite small, and the data has not been cleaned yet, so please interpret these data with care. The data cut was may 15th, up to that time, we have observed 73.9% patients with TEAE and 60.9% with grade 3 or more TEAE. Nearly 40% of them reported with serious TEAE.
We have 35% patients who have TEAE leading to dose delay but only one patients leading to dose reduction. The data is still changing, but now, we see no patient had TEAE leading to withdrawal. Two of the patients had TEAE with fatal outcome but in both instances/cases, the result was not related to the drugs in our study.
Next, we will focus on the hematologic parameters. The baseline of WBC, N, HJb, and Plt counts are pretty similar in China and global.
Let’s move on to discussing the hematologic TEAE summary as of May 15.
This data suggests that half of the patients in Lonca+R arm had hematologic toxicities.
No bleeding related to the treatment were reported.
On this slide, I will show the potential reason for the high rate of neutropenia.
We think the reason for this high rate is the less use of prophylaxis medication in China, which is a difference in medical practice between different regions.
This slide shows the hematologic TEAE summary of each patient. There are no obvious differences between the two arms in this aspect. In R-GemOx, some patients only received one or two cycles of…. regimen so the TEAE hasn’t shown yet on the data.
On this last slide, I want to present the challenges and support needed in our medical monitoring work.
Some patients have also chosen to end treatment because they were not selected for the Lonca+R and have received the standard of care drugs. Which creates a potential bias in the result.
Do you have any suggestions about any other things we can do?
Pronunciation
paRAmeters
hematoLOgic
toxiCIties
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