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I am still going through the SDNO 2020 abstracts and presentations. Already sat through 5 days of lectures! It is overwhelming. Here are some of what I think were the highlights. If anyone else went to the meeting, feel free to add what you saw!
1. Optune had 43 presentations. All were positive – even the ones not funded by Novocure! Highlights include a long term update from the very first trial of 10 newly diagnosed and 10 recurrent glioblastoma patients. 20% of the patients (2 from each group) are still alive at around the 15 year mark. This is unheard of.
New data from the registry shows a benefit (100% increase but it was only from 1.6 to 3.3 months) of Optune over the best of doctor’s choice for recurrent Glioblastoma. The original trial showed them to be equal but Optune having better quality of life and less side effects.
2. RESPECT™ PHASE 1 CLINICAL TRIAL IN RECURRENT GLIOBLASTOMA from Plus Therapeutics showed impressive results even though a phase 1 trial is not really looking for survival advantage.
3. Val-083: Phase 2 study results in recurrent unmethylated MGMT, Avastin Naïve Glioblastoma showed an impressive progression free survival in this difficult to treat group of patients.
4. LTBK-01 - INO-5401 and INO-9012 delivered intramuscularly (IM) with electroporation (EP) in combination with cemiplimab (REGN2810) in newly diagnosed glioblastoma. Preliminary results show impressive progression free and overall survival. The unmethylated MGMT group did not use Temodar except during radiation and did better than historical data on Temodar.
5. DNX2401 impressive results with recurrent gbm. 12.5 month median survival 54% clinical benefit rate.
6. Small study shows No benefit of Temodar in IDH1/2 wildtype Anaplastic astrocytoma or glioblastoma , but big benefit in IDH1/2 mutant tumors. This is too small to be practice changing but it is the first time I ever heard that Temodar might be useless in most glioblastomas. More research needs to be done.
7. Onc-201 Patients with H3 K27M-mutant DMG treated with ONC201 on active clinical trials (n=50, 27 thalamic, 23 brainstem) showed an overall survival (OS) of 28.1 (range: 5.9-105) months from diagnosis (enrollment by 4/29/19, data cut-off 12/28/19), compared to historical median OS of 12 months. Median OS for non-recurrent patients has not been reached (n=16, median follow-up: 16.8 from diagnosis). For non-recurrent thalamic patients (n=8), median PFS is 20.1 (range: 9.3-27.6) months from diagnosis (median time on drug: 14.5 months). Best response for thalamic patients by RANO: 1 CR, 5 PR, 7 SD, 8 PD, 6 not reported. This is way better than the currently used treatments and in my opion should be approved by the FDA immediately. Once it is approved we can try to figure out ways to make it work better.
8. Most important lecture of the conference (in my opinion): Dr Johanna A. Joyce talking about microenviorment. It has a huge effect on outcome and has to be addressed. She says we need to combine drugs that each by itself doesn’t do much but in the right combinations can make a huge difference! (Sound familiar?)
9. ERC1671 (Gliovac) for recurrent gbm: Showed median os of 10.8 months compared to randomized control of 6 month. No significant side effects. Again - this type of treatment needs to be approved so we can utilize them in combinations to find the cure!
10. NCT03223103 Personalized vaccine + tumor treating fields. This is very early results in a small group of patients but looks good so far. 12 month PFS of 62.5% and 12 month os of 83%. Median survival not yet reached as 7 of the 9 patients were still alive at the data cutoff point.
11. Poly ICLC + a DC vaccine in randomized trial shows a major improvement in OS and TTP. Hard to interpret the poster – they do not say if these are newly diagnosed or recurrent and they mix grade 3 and 4 but it was randomized. IF DCVAX gets approved soon, the first thing we should try is adding Poly ICLC to it!
12. OKN-007 increases sensitivity to temozolomide. Very early results but looks promising. 20 month median overall survival for recurrent gbm for patients in the highest dosage group. There is a big dose response curve which indicates that the drug has an effect.
13. BNCT Small trial but impressive results for recurrent gbm: 1 year survival was 79% and median OS was 18.7 months.
I am still going through the SDNO 2020 abstracts and presentations. Already sat through 5 days of lectures! It is overwhelming. Here are some of what I think were the highlights. If anyone else went to the meeting, feel free to add what you saw!
1. Optune had 43 presentations. All were positive – even the ones not funded by Novocure! Highlights include a long term update from the very first trial of 10 newly diagnosed and 10 recurrent glioblastoma patients. 20% of the patients (2 from each group) are still alive at around the 15 year mark. This is unheard of.
New data from the registry shows a benefit (100% increase but it was only from 1.6 to 3.3 months) of Optune over the best of doctor’s choice for recurrent Glioblastoma. The original trial showed them to be equal but Optune having better quality of life and less side effects.
2. RESPECT™ PHASE 1 CLINICAL TRIAL IN RECURRENT GLIOBLASTOMA from Plus Therapeutics showed impressive results even though a phase 1 trial is not really looking for survival advantage.
3. Val-083: Phase 2 study results in recurrent unmethylated MGMT, Avastin Naïve Glioblastoma showed an impressive progression free survival in this difficult to treat group of patients.
4. LTBK-01 - INO-5401 and INO-9012 delivered intramuscularly (IM) with electroporation (EP) in combination with cemiplimab (REGN2810) in newly diagnosed glioblastoma. Preliminary results show impressive progression free and overall survival. The unmethylated MGMT group did not use Temodar except during radiation and did better than historical data on Temodar.
5. DNX2401 impressive results with recurrent gbm. 12.5 month median survival 54% clinical benefit rate.
6. Small study shows No benefit of Temodar in IDH1/2 wildtype Anaplastic astrocytoma or glioblastoma , but big benefit in IDH1/2 mutant tumors. This is too small to be practice changing but it is the first time I ever heard that Temodar might be useless in most glioblastomas. More research needs to be done.
7. Onc-201 Patients with H3 K27M-mutant DMG treated with ONC201 on active clinical trials (n=50, 27 thalamic, 23 brainstem) showed an overall survival (OS) of 28.1 (range: 5.9-105) months from diagnosis (enrollment by 4/29/19, data cut-off 12/28/19), compared to historical median OS of 12 months. Median OS for non-recurrent patients has not been reached (n=16, median follow-up: 16.8 from diagnosis). For non-recurrent thalamic patients (n=8), median PFS is 20.1 (range: 9.3-27.6) months from diagnosis (median time on drug: 14.5 months). Best response for thalamic patients by RANO: 1 CR, 5 PR, 7 SD, 8 PD, 6 not reported. This is way better than the currently used treatments and in my opion should be approved by the FDA immediately. Once it is approved we can try to figure out ways to make it work better.
8. Most important lecture of the conference (in my opinion): Dr Johanna A. Joyce talking about microenviorment. It has a huge effect on outcome and has to be addressed. She says we need to combine drugs that each by itself doesn’t do much but in the right combinations can make a huge difference! (Sound familiar?)
9. ERC1671 (Gliovac) for recurrent gbm: Showed median os of 10.8 months compared to randomized control of 6 month. No significant side effects. Again - this type of treatment needs to be approved so we can utilize them in combinations to find the cure!
10. NCT03223103 Personalized vaccine + tumor treating fields. This is very early results in a small group of patients but looks good so far. 12 month PFS of 62.5% and 12 month os of 83%. Median survival not yet reached as 7 of the 9 patients were still alive at the data cutoff point.
11. Poly ICLC + a DC vaccine in randomized trial shows a major improvement in OS and TTP. Hard to interpret the poster – they do not say if these are newly diagnosed or recurrent and they mix grade 3 and 4 but it was randomized. IF DCVAX gets approved soon, the first thing we should try is adding Poly ICLC to it!
12. OKN-007 increases sensitivity to temozolomide. Very early results but looks promising. 20 month median overall survival for recurrent gbm for patients in the highest dosage group. There is a big dose response curve which indicates that the drug has an effect.
13. BNCT Small trial but impressive results for recurrent gbm: 1 year survival was 79% and median OS was 18.7 months.
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