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The 2021 American Society of Clinical Oncology (ASCO) Annual Meeting will be held on June 4-8, 2021 Eastern Time
.
At this conference, the efficacy and safety data of the monarchE study in the Chinese population was announced.
The therapeutic value of Abexicil in the Chinese population has once again been highlighted.
This result is expected to change the treatment model of early breast cancer in China
.
In addition, the results of the FUTURE-C-PLUS study led by Professor Shao Zhimin were selected as an oral report by ASCO.
"Fudan classification" opens a new chapter for precision treatment of refractory triple-negative breast cancer! We specially invited China's leading PI from monarchE research and Professor Shao Zhimin from Fudan University Cancer Hospital to interpret these two studies
.
Reporter: Most hormone receptor (HR)-positive early breast cancers will not recur after standard treatment, but there are still some patients who will have disease recurrence and distant metastasis within 10 years
.
Could you please introduce the high risk factors for recurrence of HR-positive breast cancer? Professor Shao Zhimin: Breast cancer can be divided into three to four different subtypes, of which the proportion of luminal type is relatively high, accounting for about 60%-65% in the Chinese population, and more than 70% in the European and American population
.
Its main feature is that it is effective in endocrine therapy, with a low risk of early recurrence, but a significantly higher risk of late recurrence (compared with HER2-positive and triple-negative breast cancer)
.
There are some clinical indicators to determine whether a patient has high-risk recurrence risk factors.
Lymph node metastasis is the most important sign.
The long-term recurrence risk of luminal breast cancer with lymph node metastasis is significantly increased
.
Basal in the Luminal type, that is, patients with estrogen receptor positive and progesterone receptor negative have poor effect on endocrine therapy, so there is also a risk of long-term recurrence
.
In addition, the size of the tumor, whether there is a vascular tumor thrombus, etc.
, are all criteria for our judgment
.
In the laboratory, we are exploring the genetic nature of luminal breast cancer, and found that there are actually some subtypes in the luminal type, and the risk of long-term recurrence of certain subtypes of breast cancer is significantly increased.
.
Reporter: This year's ASCO conference released the Chinese population data of the monarchE study.
As the leading Chinese leader of the study, can you interpret the validity data of the Chinese population of the study and the significance of the data for Chinese breast cancer patients? Professor Shao Zhimin: For patients with luminal breast cancer who are at high risk of long-term recurrence, the current strategy is to extend the endocrine therapy, but there are still some patients who relapse
.
Studies have found that CDK4 & 6 inhibitors are effective for recurrent and metastatic breast cancer, so can they be moved forward to adjuvant therapy? Whether the combination of CDK4 & 6 inhibitors and endocrine therapy can further reduce the risk of recurrence and metastasis of patients is also a very important clinical scientific problem to be solved by monarchE research
.
As the Leading PI in China, I participated in the global monarchE clinical trial
.
The monarchE study of the two-year non-invasive disease survival (IDFS) rate is undoubtedly meaningful
.
In the Chinese population, the two-year risk of recurrence has been reduced by about 34%
.
So from the early data, we can see that it has a certain effect
.
We also look forward to the data three or five years later, which can bring benefits to patients, which will be of great significance for reducing the risk of long-term recurrence of luminal breast cancer
.
MonarchE research Chinese population IDFS reporter: In the treatment of early breast cancer, the safety profile of the drug is very important for patients to adhere to the treatment
.
Can you interpret the safety data of the monarchE study of the Chinese population, including the similarities and differences with the global population as a whole? Professor Shao Zhimin: The adjuvant therapy drugs have been taken for one or two years, and safety is also very important
.
According to the data of the Chinese population studied by monarchE, the adverse reactions of the Abbecili group are mainly manifested in diarrhea and blood system, such as mild anemia and leukopenia
.
However, after treatment, the proportion of drug withdrawal decreased significantly
.
Therefore, clinically, adverse reactions are completely controllable
.
Moreover, the safety of the Chinese population is the same as that of the global population
.
Reporter: This year's ASCO conference also released the results of the FUTURE-C-PLUS clinical research led by you
.
We have been paying attention to the proposal and optimization of the "Fudan Classification", to the FUTURE trial that brings light to patients who have failed multi-line treatment, and to FUTURE-C-PLUS to bring inspiring results for first-line treatment
.
What do you think of the future research direction of breast cancer precision treatment led by the FUTURE trial? Professor Shao Zhimin: Triple-negative breast cancer is very difficult to treat.
It has no specific target.
Once it recurs and metastasizes, chemotherapy alone has poor effect, rapid progress, and a higher risk of early recurrence
.
For triple-negative breast cancer, many researchers are exploring
.
After five or six years of exploration in Fudan Tumor, we found that triple-negative breast cancer includes different subtypes with strong heterogeneity
.
Between different subtypes, there are different treatment methods according to their targets
.
Therefore, we designed a FUTURE clinical trial after failure of multi-line therapy, and differentiated treatments based on the availability and classification of drugs
.
It was found that among 7-8 different arms, several arms have very good effects
.
For example, in the androgen receptor-positive type, if the patient has a HER2 gene mutation, the effect of anti-HER2 therapy combined with chemotherapy is very good
.
In the immunomodulatory type, the effective rate of PD-L1 immunotherapy combined with chemotherapy is as high as 52%
.
In the basal cell-like subtype, the use of anti-angiogenesis combined with chemotherapy has an effective rate of 29%
.
But this does not mean complete success
.
For example, in the androgen receptor-positive type, the use of CDK4 & 6 inhibitors and anti-androgen therapy is not effective.
We are still exploring and continuously optimizing
.
Since the immunomodulatory type after the failure of multi-line therapy is very effective with immunotherapy combined with chemotherapy, we have taken a step forward and designed the Phase II, single-arm clinical trial FUTURE-C-PLUS study to explore the use of this treatment strategy for three The efficacy of first-line treatment after recurrence and metastasis of negative breast cancer
.
The study found that the effective rate is as high as 81.
3%
.
The PFS has not yet been reached and is expected to exceed 11 months
.
This is the best curative effect currently achieved in triple-negative breast cancer.
It was selected as an oral report at this year’s ASCO conference.
The results of this study are very encouraging for the treatment of triple-negative breast cancer
.
If this treatment concept continues to move forward and is applied to the neoadjuvant and adjuvant phases, I believe the efficacy of triple-negative breast cancer patients will be significantly improved
.
About the monarchE study monarchE is a randomized, open-label, multi-center phase III clinical study that enrolled 5637 lymph node-positive HR+ and HER2-high-risk early breast cancer patients
.
Participants were randomly assigned 1:1 to abexicide (150 mg, twice a day) combined with standard adjuvant endocrine therapy group, or standard adjuvant endocrine therapy group alone (ET group)
.
The primary end point is IDFS based on the "Efficacy Endpoint Standard Definition" (STEEP) standard
.
Secondary endpoints include: distant relapse-free survival (DRFS), overall survival, safety, pharmacokinetics, and health outcomes
.
monarchE research design The 2020 ESMO conference and JCO magazine simultaneously reported the results of the second interim analysis (IA2) of the research
.
With a median follow-up of 15.
5 months, a total of 323 IDFS events were observed (136 in the Abbecili group and 187 in the ET group alone)
.
Compared with ET alone, abecili+ET significantly reduced the risk of aggressive disease by 25% (HR 0.
747, 95% CI 0.
598-0.
932, P=0.
0096), and the 2-year IDFS rates were 92.
2% and 88.
7%, respectively; significantly reduced The risk of distant metastasis was 28% (HR 0.
717, 95% CI 0.
559-0.
920, P=0.
0085), and the 2-year DRFS rates were 93.
6% and 90.
3%, respectively
.
The 2020 SABCS conference reported updated data from monarchE research
.
With a median follow-up of 19.
1 months, a total of 395 IDFS events were observed (163 cases in the abecili group and 232 cases in the ET group alone)
.
Compared with ET alone, Abexiride+ET significantly reduced the risk of invasive disease by 29% (HR 0.
713, 95% CI 0.
583-0.
871, P=0.
0009), and the 2-year IDFS rates were 92.
3% and 89.
3%, respectively.
The benefit is 3.
0%
.
The primary endpoint IDFS 2021 ASCO conference announced the efficacy and safety data of the monarchE study in Chinese patients
.
A total of 501 Chinese patients were randomized to receive abexiride combined with ET (259 cases) or ET alone (242 cases)
.
As of July 8, 2020, a total of 26 IDFS events have been observed (11 cases in the abecili group and 15 cases in the ET group alone)
.
Compared with ET alone, Abexicil+ET reduced the risk of invasive disease or death in Chinese patients by 34.
3% (HR 0.
657, 95% CI 0.
301-1.
435), and the 2-year IDFS rate also achieved a clinically significant improvement ( 95.
6% vs 92.
1%)
.
The addition of abecilil on the basis of ET can improve the DRFS of Chinese patients (HR 0.
601, 95% CI 0.
245-1.
477), and the 2-year DRFS rate was 96.
7% (93.
4% in the ET single-agent group)
.
The combination of Abexili and ET showed clinically significant IDFS and DRFS benefits in Chinese patients, consistent with the previously reported ITT population
.
In terms of safety, the most common adverse reactions (TEAE) and grade ≥3 TEAE during the treatment period of Abbexilide combined with ET were: diarrhea (90.
3% and 5.
0%), leukopenia (76.
8% and 21.
2%) ) And decreased neutrophils (76.
4% and 23.
9%)
.
The safety profile of Abexicil in Chinese patients is consistent with that of the global population
.
.
At this conference, the efficacy and safety data of the monarchE study in the Chinese population was announced.
The therapeutic value of Abexicil in the Chinese population has once again been highlighted.
This result is expected to change the treatment model of early breast cancer in China
.
In addition, the results of the FUTURE-C-PLUS study led by Professor Shao Zhimin were selected as an oral report by ASCO.
"Fudan classification" opens a new chapter for precision treatment of refractory triple-negative breast cancer! We specially invited China's leading PI from monarchE research and Professor Shao Zhimin from Fudan University Cancer Hospital to interpret these two studies
.
Reporter: Most hormone receptor (HR)-positive early breast cancers will not recur after standard treatment, but there are still some patients who will have disease recurrence and distant metastasis within 10 years
.
Could you please introduce the high risk factors for recurrence of HR-positive breast cancer? Professor Shao Zhimin: Breast cancer can be divided into three to four different subtypes, of which the proportion of luminal type is relatively high, accounting for about 60%-65% in the Chinese population, and more than 70% in the European and American population
.
Its main feature is that it is effective in endocrine therapy, with a low risk of early recurrence, but a significantly higher risk of late recurrence (compared with HER2-positive and triple-negative breast cancer)
.
There are some clinical indicators to determine whether a patient has high-risk recurrence risk factors.
Lymph node metastasis is the most important sign.
The long-term recurrence risk of luminal breast cancer with lymph node metastasis is significantly increased
.
Basal in the Luminal type, that is, patients with estrogen receptor positive and progesterone receptor negative have poor effect on endocrine therapy, so there is also a risk of long-term recurrence
.
In addition, the size of the tumor, whether there is a vascular tumor thrombus, etc.
, are all criteria for our judgment
.
In the laboratory, we are exploring the genetic nature of luminal breast cancer, and found that there are actually some subtypes in the luminal type, and the risk of long-term recurrence of certain subtypes of breast cancer is significantly increased.
.
Reporter: This year's ASCO conference released the Chinese population data of the monarchE study.
As the leading Chinese leader of the study, can you interpret the validity data of the Chinese population of the study and the significance of the data for Chinese breast cancer patients? Professor Shao Zhimin: For patients with luminal breast cancer who are at high risk of long-term recurrence, the current strategy is to extend the endocrine therapy, but there are still some patients who relapse
.
Studies have found that CDK4 & 6 inhibitors are effective for recurrent and metastatic breast cancer, so can they be moved forward to adjuvant therapy? Whether the combination of CDK4 & 6 inhibitors and endocrine therapy can further reduce the risk of recurrence and metastasis of patients is also a very important clinical scientific problem to be solved by monarchE research
.
As the Leading PI in China, I participated in the global monarchE clinical trial
.
The monarchE study of the two-year non-invasive disease survival (IDFS) rate is undoubtedly meaningful
.
In the Chinese population, the two-year risk of recurrence has been reduced by about 34%
.
So from the early data, we can see that it has a certain effect
.
We also look forward to the data three or five years later, which can bring benefits to patients, which will be of great significance for reducing the risk of long-term recurrence of luminal breast cancer
.
MonarchE research Chinese population IDFS reporter: In the treatment of early breast cancer, the safety profile of the drug is very important for patients to adhere to the treatment
.
Can you interpret the safety data of the monarchE study of the Chinese population, including the similarities and differences with the global population as a whole? Professor Shao Zhimin: The adjuvant therapy drugs have been taken for one or two years, and safety is also very important
.
According to the data of the Chinese population studied by monarchE, the adverse reactions of the Abbecili group are mainly manifested in diarrhea and blood system, such as mild anemia and leukopenia
.
However, after treatment, the proportion of drug withdrawal decreased significantly
.
Therefore, clinically, adverse reactions are completely controllable
.
Moreover, the safety of the Chinese population is the same as that of the global population
.
Reporter: This year's ASCO conference also released the results of the FUTURE-C-PLUS clinical research led by you
.
We have been paying attention to the proposal and optimization of the "Fudan Classification", to the FUTURE trial that brings light to patients who have failed multi-line treatment, and to FUTURE-C-PLUS to bring inspiring results for first-line treatment
.
What do you think of the future research direction of breast cancer precision treatment led by the FUTURE trial? Professor Shao Zhimin: Triple-negative breast cancer is very difficult to treat.
It has no specific target.
Once it recurs and metastasizes, chemotherapy alone has poor effect, rapid progress, and a higher risk of early recurrence
.
For triple-negative breast cancer, many researchers are exploring
.
After five or six years of exploration in Fudan Tumor, we found that triple-negative breast cancer includes different subtypes with strong heterogeneity
.
Between different subtypes, there are different treatment methods according to their targets
.
Therefore, we designed a FUTURE clinical trial after failure of multi-line therapy, and differentiated treatments based on the availability and classification of drugs
.
It was found that among 7-8 different arms, several arms have very good effects
.
For example, in the androgen receptor-positive type, if the patient has a HER2 gene mutation, the effect of anti-HER2 therapy combined with chemotherapy is very good
.
In the immunomodulatory type, the effective rate of PD-L1 immunotherapy combined with chemotherapy is as high as 52%
.
In the basal cell-like subtype, the use of anti-angiogenesis combined with chemotherapy has an effective rate of 29%
.
But this does not mean complete success
.
For example, in the androgen receptor-positive type, the use of CDK4 & 6 inhibitors and anti-androgen therapy is not effective.
We are still exploring and continuously optimizing
.
Since the immunomodulatory type after the failure of multi-line therapy is very effective with immunotherapy combined with chemotherapy, we have taken a step forward and designed the Phase II, single-arm clinical trial FUTURE-C-PLUS study to explore the use of this treatment strategy for three The efficacy of first-line treatment after recurrence and metastasis of negative breast cancer
.
The study found that the effective rate is as high as 81.
3%
.
The PFS has not yet been reached and is expected to exceed 11 months
.
This is the best curative effect currently achieved in triple-negative breast cancer.
It was selected as an oral report at this year’s ASCO conference.
The results of this study are very encouraging for the treatment of triple-negative breast cancer
.
If this treatment concept continues to move forward and is applied to the neoadjuvant and adjuvant phases, I believe the efficacy of triple-negative breast cancer patients will be significantly improved
.
About the monarchE study monarchE is a randomized, open-label, multi-center phase III clinical study that enrolled 5637 lymph node-positive HR+ and HER2-high-risk early breast cancer patients
.
Participants were randomly assigned 1:1 to abexicide (150 mg, twice a day) combined with standard adjuvant endocrine therapy group, or standard adjuvant endocrine therapy group alone (ET group)
.
The primary end point is IDFS based on the "Efficacy Endpoint Standard Definition" (STEEP) standard
.
Secondary endpoints include: distant relapse-free survival (DRFS), overall survival, safety, pharmacokinetics, and health outcomes
.
monarchE research design The 2020 ESMO conference and JCO magazine simultaneously reported the results of the second interim analysis (IA2) of the research
.
With a median follow-up of 15.
5 months, a total of 323 IDFS events were observed (136 in the Abbecili group and 187 in the ET group alone)
.
Compared with ET alone, abecili+ET significantly reduced the risk of aggressive disease by 25% (HR 0.
747, 95% CI 0.
598-0.
932, P=0.
0096), and the 2-year IDFS rates were 92.
2% and 88.
7%, respectively; significantly reduced The risk of distant metastasis was 28% (HR 0.
717, 95% CI 0.
559-0.
920, P=0.
0085), and the 2-year DRFS rates were 93.
6% and 90.
3%, respectively
.
The 2020 SABCS conference reported updated data from monarchE research
.
With a median follow-up of 19.
1 months, a total of 395 IDFS events were observed (163 cases in the abecili group and 232 cases in the ET group alone)
.
Compared with ET alone, Abexiride+ET significantly reduced the risk of invasive disease by 29% (HR 0.
713, 95% CI 0.
583-0.
871, P=0.
0009), and the 2-year IDFS rates were 92.
3% and 89.
3%, respectively.
The benefit is 3.
0%
.
The primary endpoint IDFS 2021 ASCO conference announced the efficacy and safety data of the monarchE study in Chinese patients
.
A total of 501 Chinese patients were randomized to receive abexiride combined with ET (259 cases) or ET alone (242 cases)
.
As of July 8, 2020, a total of 26 IDFS events have been observed (11 cases in the abecili group and 15 cases in the ET group alone)
.
Compared with ET alone, Abexicil+ET reduced the risk of invasive disease or death in Chinese patients by 34.
3% (HR 0.
657, 95% CI 0.
301-1.
435), and the 2-year IDFS rate also achieved a clinically significant improvement ( 95.
6% vs 92.
1%)
.
The addition of abecilil on the basis of ET can improve the DRFS of Chinese patients (HR 0.
601, 95% CI 0.
245-1.
477), and the 2-year DRFS rate was 96.
7% (93.
4% in the ET single-agent group)
.
The combination of Abexili and ET showed clinically significant IDFS and DRFS benefits in Chinese patients, consistent with the previously reported ITT population
.
In terms of safety, the most common adverse reactions (TEAE) and grade ≥3 TEAE during the treatment period of Abbexilide combined with ET were: diarrhea (90.
3% and 5.
0%), leukopenia (76.
8% and 21.
2%) ) And decreased neutrophils (76.
4% and 23.
9%)
.
The safety profile of Abexicil in Chinese patients is consistent with that of the global population
.
