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*Only for medical professionals to read and reference for 1 minute a day, to give you professional "talks" in the tumor circle! (If you need the original text, you can add the editor's WeChat yxj_oncology to get it) Key points: Lancet Oncol: D+T combined with radiotherapy failed to further increase the objective response rate of patients with non-small cell lung cancer (NSCLC) Annals of Oncology: ROAR study data update, Dara Fenib + trametinib has a considerable effect on this type of thyroid cancer New drug: The study of sugalimab in the treatment of relapsed and refractory lymphoma achieved the primary endpoint, and plans to submit a marketing application New drug: The innovative cancer vaccine entered Phase II/III clinical trials Combined use can improve the efficacy of immune checkpoint inhibitors 01Lancet Oncol: D+T combined with radiotherapy failed to further increase the objective response rate of non-small cell lung cancer (NSCLC) patients Currently, studies have confirmed that radiotherapy can enhance anti-tumor immunity
.
On January 13, a study exploring the potential benefit of combination therapy with the PD-L1 inhibitor durvalumab plus CTLA-4 inhibitor (Tremelimumab) (D+T) or further with radiotherapy was published in The Lancet Oncol
.
The results showed that for PD-(L)1-resistant NSCLC patients, the combination of D+T combined with radiotherapy did not increase the objective response rate (ORR)
.
Screenshot of the journal's official website This open-label, multicenter, randomized, phase II trial was conducted at 18 research centers in the United States
.
The study enrolled patients with metastatic NSCLC aged ≥18 years, ECOG score 0 or 1, and disease progression during previous PD-(L)1 therapy, randomly assigned (1:1:1) to receive durvalumab (1500 mg) Intravenous every 4 weeks for up to 13 cycles) plus Tremelimumab (75 mg IV every 4 weeks for up to 4 cycles), or further low-dose radiation therapy (0.
5 Gy twice daily) , repeated 2 days in each of the first 4 treatment cycles) or hypofractionated RT (24 Gy in 3 divided doses in the first cycle only), 1 week after the initial D+T administration
.
The primary endpoint was ORR
.
A total of 78 patients (26 in each group) were treated between August 24, 2017, and March 29, 2019
.
The trial was discontinued because the interim analysis was invalid
.
At a median follow-up of 12.
4 months (IQR 7.
8–15.
1), the combined D+T group (3/26 cases, 11.
5%; 90% CI 1.
2%-21.
8%) and the low-dose RT group (2/26 cases, 7.
7%; 90% CI 0.
0%-16.
3%; p=0.
64) and the hypofractionated RT group (3/26 patients, 11.
5%; 90% CI 1.
2-21.
8; p=0.
99) in the overall response rate
.
The most common grade 3-4 adverse events were dyspnea (2 patients in the D+T group, 8%; 3 patients in the low-dose RT group, 12%; and 3 patients in the hypofractionated RT group, 12%) and hyponatremia ( 1 case in the D+T treatment group, 4% vs 2 cases in the low-dose RT group, 8% vs 3 cases in the hypofractionated RT group, 12%)
.
Treatment-related serious adverse events occurred in 1 patient (4%, maculopapular rash) in the D+T group and 5 patients (19%, abdominal pain, diarrhea, dyspnea, hypokalemia, and respiratory failure) in the low-dose radiotherapy group.
There were 4 patients in the hypofractionated RT group (15%, adrenal insufficiency, colitis, diarrhea, and hyponatremia)
.
In the low-dose radiotherapy group, there was 1 death from respiratory failure possibly related to study treatment
.
02Annals of Oncology: ROAR study data update, dabrafenib + trametinib has a considerable effect on this type of thyroid cancer Approved for the treatment of BRAF V600E-mutated anaplastic thyroid cancer (ATC)
.
Recently, updated data from the ROAR study were published in Annals of Oncology
.
The updated results further confirmed the significant activity and manageable toxicity of dabrafenib + trametinib in BRAF V600E mutant ATC
.
Screenshot of the journal's official website ROAR is an open-label, non-randomized, phase II basket study designed to evaluate dabrafenib + trametinib in the treatment of rare cancers with BRAF V600E mutations
.
Its ATC cohort included 36 patients with unresectable or metastatic ATC who received dabrafenib (150 mg twice daily) + trametinib (2 mg orally once daily) until disease progression or intolerance Toxicity or death
.
The primary endpoint was ORR as assessed by investigator RECIST v1.
1
.
Secondary endpoints included duration of response (DoR), progression-free survival (PFS), overall survival (OS) and safety
.
At the data cutoff date (September 14, 2020), the median follow-up was 11.
1 months (range: 0.
9-76.
6 months)
.
The investigator-assessed ORR was 56% (95% CI 38.
1%-72.
1%), including 3 complete responses; the 12-month DoR rate was 50%
.
Median PFS and OS were 6.
7 months and 14.
5 months, respectively
.
The 12-month PFS and OS rates were 43.
2% and 51.
7%, respectively, and the 24-month OS rate was 31.
5%
.
Additional follow-up revealed no new safety signals
.
03New drug: The study of sugalimumab in the treatment of relapsed and refractory lymphoma reached the primary endpoint and plans to submit a marketing application.
CStone announced on January 13 that the GEMSTONE-201 study of its PD-L1 monoclonal antibody sugelimumab achieved the primary endpoint
.
Phase II clinical trial for the treatment of relapsed or refractory extranodal natural killer cell/T cell lymphoma (R/R ENKTL)
.
GEMSTONE-201 is a single-arm, multicenter Phase II study evaluating sugelimumab as monotherapy in relapsed or refractory extranodal natural killer cell/T-cell lymphoma (R/R ENKTL) effectiveness and safety
.
The results showed that sugelimab exhibited considerable activity and good safety in R/R ENKTL patients
.
CStone plans to submit an NDA for the R/R ENKTL indication of sugelimab to the National Medical Products Administration (NMPA) in the near future
.
In view of this, sugelimab is expected to become the world's first immunotherapy drug approved for this indication
.
04New Drugs: Innovative cancer vaccines enter Phase II/III clinical trials, and combined use can improve the efficacy of immune checkpoint inhibitorsGritstone bio announced on January 13 that its investigational cancer vaccine GRANITE combined with immune checkpoint inhibitors for first-line maintenance therapy was newly diagnosed A Phase II/III clinical trial of microsatellite stable (MSS) metastatic colorectal cancer (mCRC) has completed the first patient enrollment
.
GRANITE has previously received Fast Track designation from the U.
S.
Food and Drug Administration (FDA) for the treatment of patients with MSS-type mCRC
.
References: 1.
Schoenfeld JD, et al.
The Lancet Oncology.
13 Jan 2022.
DOI: https://doi.
org/10.
1016/S1470-2045(21)00658-6.
https:// /journals/lanonc/article/PIIS1470-2045(21)00658-6/fulltext2.
Subbiah V, et al.
Annals of Oncology.
10 Jan 2022.
: https://doi.
org/10.
1016/j.
annonc.
2021.
12.
014.
https:// qq.
com/s/qJ_xwTYxcixqKYiXHnvo0w
.
On January 13, a study exploring the potential benefit of combination therapy with the PD-L1 inhibitor durvalumab plus CTLA-4 inhibitor (Tremelimumab) (D+T) or further with radiotherapy was published in The Lancet Oncol
.
The results showed that for PD-(L)1-resistant NSCLC patients, the combination of D+T combined with radiotherapy did not increase the objective response rate (ORR)
.
Screenshot of the journal's official website This open-label, multicenter, randomized, phase II trial was conducted at 18 research centers in the United States
.
The study enrolled patients with metastatic NSCLC aged ≥18 years, ECOG score 0 or 1, and disease progression during previous PD-(L)1 therapy, randomly assigned (1:1:1) to receive durvalumab (1500 mg) Intravenous every 4 weeks for up to 13 cycles) plus Tremelimumab (75 mg IV every 4 weeks for up to 4 cycles), or further low-dose radiation therapy (0.
5 Gy twice daily) , repeated 2 days in each of the first 4 treatment cycles) or hypofractionated RT (24 Gy in 3 divided doses in the first cycle only), 1 week after the initial D+T administration
.
The primary endpoint was ORR
.
A total of 78 patients (26 in each group) were treated between August 24, 2017, and March 29, 2019
.
The trial was discontinued because the interim analysis was invalid
.
At a median follow-up of 12.
4 months (IQR 7.
8–15.
1), the combined D+T group (3/26 cases, 11.
5%; 90% CI 1.
2%-21.
8%) and the low-dose RT group (2/26 cases, 7.
7%; 90% CI 0.
0%-16.
3%; p=0.
64) and the hypofractionated RT group (3/26 patients, 11.
5%; 90% CI 1.
2-21.
8; p=0.
99) in the overall response rate
.
The most common grade 3-4 adverse events were dyspnea (2 patients in the D+T group, 8%; 3 patients in the low-dose RT group, 12%; and 3 patients in the hypofractionated RT group, 12%) and hyponatremia ( 1 case in the D+T treatment group, 4% vs 2 cases in the low-dose RT group, 8% vs 3 cases in the hypofractionated RT group, 12%)
.
Treatment-related serious adverse events occurred in 1 patient (4%, maculopapular rash) in the D+T group and 5 patients (19%, abdominal pain, diarrhea, dyspnea, hypokalemia, and respiratory failure) in the low-dose radiotherapy group.
There were 4 patients in the hypofractionated RT group (15%, adrenal insufficiency, colitis, diarrhea, and hyponatremia)
.
In the low-dose radiotherapy group, there was 1 death from respiratory failure possibly related to study treatment
.
02Annals of Oncology: ROAR study data update, dabrafenib + trametinib has a considerable effect on this type of thyroid cancer Approved for the treatment of BRAF V600E-mutated anaplastic thyroid cancer (ATC)
.
Recently, updated data from the ROAR study were published in Annals of Oncology
.
The updated results further confirmed the significant activity and manageable toxicity of dabrafenib + trametinib in BRAF V600E mutant ATC
.
Screenshot of the journal's official website ROAR is an open-label, non-randomized, phase II basket study designed to evaluate dabrafenib + trametinib in the treatment of rare cancers with BRAF V600E mutations
.
Its ATC cohort included 36 patients with unresectable or metastatic ATC who received dabrafenib (150 mg twice daily) + trametinib (2 mg orally once daily) until disease progression or intolerance Toxicity or death
.
The primary endpoint was ORR as assessed by investigator RECIST v1.
1
.
Secondary endpoints included duration of response (DoR), progression-free survival (PFS), overall survival (OS) and safety
.
At the data cutoff date (September 14, 2020), the median follow-up was 11.
1 months (range: 0.
9-76.
6 months)
.
The investigator-assessed ORR was 56% (95% CI 38.
1%-72.
1%), including 3 complete responses; the 12-month DoR rate was 50%
.
Median PFS and OS were 6.
7 months and 14.
5 months, respectively
.
The 12-month PFS and OS rates were 43.
2% and 51.
7%, respectively, and the 24-month OS rate was 31.
5%
.
Additional follow-up revealed no new safety signals
.
03New drug: The study of sugalimumab in the treatment of relapsed and refractory lymphoma reached the primary endpoint and plans to submit a marketing application.
CStone announced on January 13 that the GEMSTONE-201 study of its PD-L1 monoclonal antibody sugelimumab achieved the primary endpoint
.
Phase II clinical trial for the treatment of relapsed or refractory extranodal natural killer cell/T cell lymphoma (R/R ENKTL)
.
GEMSTONE-201 is a single-arm, multicenter Phase II study evaluating sugelimumab as monotherapy in relapsed or refractory extranodal natural killer cell/T-cell lymphoma (R/R ENKTL) effectiveness and safety
.
The results showed that sugelimab exhibited considerable activity and good safety in R/R ENKTL patients
.
CStone plans to submit an NDA for the R/R ENKTL indication of sugelimab to the National Medical Products Administration (NMPA) in the near future
.
In view of this, sugelimab is expected to become the world's first immunotherapy drug approved for this indication
.
04New Drugs: Innovative cancer vaccines enter Phase II/III clinical trials, and combined use can improve the efficacy of immune checkpoint inhibitorsGritstone bio announced on January 13 that its investigational cancer vaccine GRANITE combined with immune checkpoint inhibitors for first-line maintenance therapy was newly diagnosed A Phase II/III clinical trial of microsatellite stable (MSS) metastatic colorectal cancer (mCRC) has completed the first patient enrollment
.
GRANITE has previously received Fast Track designation from the U.
S.
Food and Drug Administration (FDA) for the treatment of patients with MSS-type mCRC
.
References: 1.
Schoenfeld JD, et al.
The Lancet Oncology.
13 Jan 2022.
DOI: https://doi.
org/10.
1016/S1470-2045(21)00658-6.
https:// /journals/lanonc/article/PIIS1470-2045(21)00658-6/fulltext2.
Subbiah V, et al.
Annals of Oncology.
10 Jan 2022.
: https://doi.
org/10.
1016/j.
annonc.
2021.
12.
014.
https:// qq.
com/s/qJ_xwTYxcixqKYiXHnvo0w
