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INTRODUCTION Indolent B-cell lymphomas (iBCLs) are a group of relatively slow-growing mature B-cell lymphomas that are more common in elderly patients
.
Follicular lymphoma (FL grades 1-3a) and marginal zone lymphoma (MZL) are two common iBCL subtypes
.
FL and MZL originate from lymphoid follicle center B cells and lymphoid follicle marginal zone, respectively
.
In recent years, with the continuous advent of new drugs and the continuous development of clinical diagnosis and treatment technology, the progression-free survival (PFS) of patients with FL/MZL has been prolonged, but some patients are faced with neutropenia and neutropenia caused by chemotherapy drugs.
The risk of infection, etc.
, reduces the compliance of patients with chemotherapy, and the curative effect is poor
.
Therefore, formulating a "chemotherapy-free" treatment plan with certain efficacy and high tolerance for FL/MZL patients who are not suitable for chemotherapy will help to improve the overall efficacy of FL/MZL treatment
.
On this occasion, Yimaitong sincerely invites Professor Feng Ru of Nanfang Hospital of Southern Medical University to share the current status of FL/MZL treatment and the progress of new drugs based on clinical experience and relevant literature
.
Standardize the treatment and management of FL/MZL disease and promote the overall improvement of the treatment level cure
.
② Asymptomatic advanced patients are usually followed up for observation and do not require treatment or can be given rituximab monotherapy
.
③ Patients with higher tumor burden are generally given rituximab-containing immunochemotherapy
.
02 "No chemotherapy" strategy: With the emergence of targeted drugs, iBCL patients with poor performance status are hopeful to obtain a targeted "no chemotherapy" treatment plan with certain efficacy and high tolerance
.
When clinicians choose a treatment plan for iBCL patients, they must first fully evaluate the patient's primary disease and physical condition
.
① A watch-and-wait strategy may be appropriate for asymptomatic patients with low tumor burden
.
② Comprehensive Geriatric Assessment (GA) can help guide decision-making, help doctors in-depth understanding of patient organ function, nutritional status, psychosocial factors, etc.
, and help predict patient survival, treatment discontinuation and hospitalization risk
.
③ When GA is not available, simple tools such as the Timed Up-and-Go (TUG) test can also be used to assess patient performance status
.
④ It is recommended that clinicians evaluate the functional status of iBCL patients and consider giving “no chemotherapy” regimen to frail patients
.
The first-line FL/MZL treatment plan has been optimized again, opening a new chapter in the first-line treatment of FL and MZL.
The first-line "chemotherapy-free" regimen currently mainly includes rituximab monotherapy, rituximab combined with lenalidomide (R2) regimen and radioimmunotherapy (see Figure 1)
.
Figure 1 Chemo-free strategies for first-line systemic therapy in FL or MZL (some strategies are used off-label in the United States) 1
.
(Note, this strategy comes from Thomas A Ollila et al Cancer Manag Res.
2021 May 14;13:3935-3952.
Recommended in the article) For FL patients with low tumor burden, rituximab monotherapy is the first-line treatment for FL/MZL Common scheme
.
Rituximab maintenance therapy was helpful in prolonging event-free survival (EFS), but there was no additional benefit from longer (5 years) maintenance therapy
.
Therefore, in the choice of regimen, the potential benefit of rituximab maintenance therapy should be weighed against the burden of long-term treatment and the associated risk of infection
.
Otuzumab, a type II glycoengineered humanized CD20 mAb, has shown good efficacy against iBCL in both relapsed/refractory and first-line therapy
.
The R2 regimen showed good antitumor activity in the treatment of FL and MZL
.
The SAKK 35/10 phase II study showed that the R2 regimen had an overall response rate (ORR) of 81% and a median PFS of 5 years, which was superior to rituximab monotherapy
.
In terms of safety, however, the R2 group had a higher rate of grade ≥3 adverse events (56% vs 22%) 1
.
Therefore, patients who expect a higher ORR or longer duration of remission may benefit from R2 therapy, but need to pay attention to the dose of lenalidomide and shorten its dosing time
.
A new exploration in the treatment of relapsed and refractory FL/MZL, the "chemotherapy-free" regimen is worth looking forward to.
The treatment regimen for patients with relapsed and refractory (R/R) FL/MZL should be based on the patient's symptoms, tumor burden, time to first remission, and intravenous administration.
The preference for drug or oral therapy determines the patient's next "chemotherapy-free" treatment strategy
.
Participation in a clinical trial is a possible option for eligible patients with poor performance status
.
Figure 2 FDA-approved chemotherapy-free strategy for the treatment of R/R FL/MZL (note that in the US, some regimens are used off-label for one or both histologic subtypes) 1
.
(This strategy comes from Thomas A Ollila et al Cancer Manag Res.
2021 May 14;13:3935-3952.
Recommended in the article) 01 Patients initially receiving rituximab monotherapy without maintenance therapy, 2 years after treatment Retreatment with rituximab may be acceptable in the event of disease progression above
.
02 For patients who can tolerate related adverse reactions, have not received first-line treatment with lenalidomide and have a creatinine clearance rate of >30mL/min, lenalidomide combined with anti-CD20 antibodies (rituximab/octuzumab) may provide an alternative treatment strategy
.
03 If the patient thinks it is troublesome to visit the infusion center frequently and wants to receive all-oral drug treatment, it is recommended to consider the following other treatment strategies ① Novel PI3K inhibitors: More specific PI3K inhibitors target the deregulated PI3K pathway, The latter is important for B cell receptor signaling, cell proliferation, and antitumor immunity
.
Currently, 4 PI3K inhibitors have been approved by the FDA for the treatment of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), follicular lymphoma and marginal zone lymphoma, namely Idelalisib, Copanlisib , Degrees Velise and Umbralisib
.
(Note: According to the information on GILD's official website, GILD has recently withdrawn the two indications of Idelalisib in the US market for recurrent FL and recurrent SLL due to the failure to complete the confirmation test required by the FDA
.
) The first-generation PI3Kδ inhibitor The patient's tolerance is poor, and common adverse reactions include infection, bone marrow suppression and inflammation (such as lung inflammation, colitis, etc.
)
.
HMPL-689 is a highly selective PI3Kδ inhibitor that highly targets PI3Kδ to reduce adverse effects resulting from inhibition of other isoforms
.
HMPL-689 has shown favorable efficacy and safety in preliminary results of its ongoing Phase Ib clinical study in Chinese R/R lymphoma patients
.
The study included 90 patients with R/R lymphoma with a median age of 57 years who received HMPL-689 30 mg daily
.
With a median follow-up of 5.
6 months, based on 76 patients with evaluable efficacy (22 in FL and 14 in MZL), the results showed that the median onset time was 1.
9 months (95%CI, 1.
84-1.
91); in the MZL subgroup, the median onset time was 1.
9 months.
In the FL subgroup, the ORR rate was 81.
8%, the CR rate was 36.
4%, the 1-year DOR rate was 59.
7% (95% CI, 15.
8-86.
6), and the 1-year PFS rate was 75.
8% (95%CI, 44.
8-90.
8)
.
The safety of the drug was manageable, and the most common grade 3 or higher treatment-related adverse events (TEAEs) in all patients were pneumonia (13.
3%) and neutropenia (11.
1%)
.
Liver and intestinal adverse reactions were mild, and AST and ALT were mildly to moderately increased in all patients (grade 1-2); the incidence of diarrhea was low, with 2.
2% of grade 3 or higher diarrhea
.
Permanent discontinuation due to AE was only 5.
6%3
.
Figure 3 Preliminary efficacy of MZL and FL patients 3 ② Ibrutinib BTK inhibitor monotherapy has not shown sufficient efficacy in FL
.
The ORR for ibrutinib in MZL was 58% (ORR was 81% for patients previously treated with rituximab alone), with a median PFS of 16 months and a median duration of response of 28 months
.
③ Tazemetostat Tazemetostat is an oral histone methyltransferase (EZH2) inhibitor, the mutation rate of EZH2 in FL is about 22%
.
In a phase II clinical trial, tazemetostat treated EZH2-mutant FL patients with an ORR of 69%, a CR rate of 13%, and a median PFS of 14 months; in EZH2 wild-type patients, ORR and CR rates were 35% and 4%, with a median PFS of 11 months
.
Tazemetostat may provide a valuable treatment option for FL patients who are candidates for Tazemetostat
.
04 Novel immunotherapy Novel immunotherapy strategies include antibody-drug conjugates (ADC), chimeric antigen receptor (CAR)-T cell therapy, bispecific antibodies, immune checkpoint inhibitors, etc.
, which have broad application prospects
.
① ADC Polatuzumab Vedotin (Pola) is an ADC targeting CD79b.
Among 20 FL patients receiving rituximab and Pola combination therapy, the ORR of the patients reached 70%, of which 45% achieved CR, and the median PFS was 15 months
.
The higher efficacy and controllable safety make the drug more suitable for elderly patients
.
② CAR-TCD19 CAR-T cells have significant curative effect in the treatment of iBCL patients
.
The ZUMA-5 phase II trial of akirenza injection enrolled patients with FL and MZL who had received ≥3 lines of therapy, had a performance status score of 0 or 1, and were up to 79 years old.
The results showed that the ORR of the patients was 92%, The CR rate was 76%
.
In terms of safety, 86% of patients experienced grade 3/4 adverse events
.
Analytical data from the Phase 2 ELARA study with a median follow-up of 17 months were presented at ASH2021
.
The results showed that the CD19 CAR-T cell therapy tisagenlecleucel was used to treat high-risk R/R FL patients, and among 94 patients with evaluable efficacy, the CR rate was 69.
1%, the ORR was 86.
2%, and the 12-month PFS was 67%
.
In terms of safety, cytokine release syndrome (CRS) occurred in 48.
5% of patients within 8 weeks of infusion, no patients experienced grade 3 or higher CRS, and 37.
1% experienced neurological events (3.
1% ≥ grade 3) , and there were no treatment-related deaths4
.
Although CAR-T cell therapy has high efficacy and potential curative effect, considering the intensity of lymphodepleting chemotherapy, the benefit/risk ratio of iBCL for the treatment of elderly or poor performance status remains to be determined
.
③ The bispecific antibody Mosunetuzumab is a CD20/CD3 bispecific antibody.
A total of 62 patients with FL were enrolled in a phase I trial for the treatment of R/R CD20-positive lymphoma.
The average age of the patients was 59 years old, and the highest age was 85 years old
.
The results showed that 68% of patients achieved remission and 50% achieved CR
.
Grade 3/4 treatment-related adverse events occurred in one-third of patients
.
Professor Feng Ru commented that both FL and MZL are common subtypes of indolent B-cell non-Hodgkin lymphoma with high heterogeneity
.
With the advent of new drugs, overall survival (OS) has improved in both diseases, and the overall survival of FL is close to 15 years5, but there are still some patients, especially those with disease progression within 24 months after first-line therapy (POD24) 6.
Facing the dilemma of refractory disease, recurrence, and poor prognosis; many FL/MZL patients are not suitable for high-intensity chemotherapy due to advanced age or comorbidities
.
It is very important to explore individualized "chemotherapy-free" regimens with high efficiency and low toxicity for such patients to reduce the risk of POD24, improve patient medication compliance, and improve patient survival and prognosis
.
"No chemotherapy" treatment has become a meaningful treatment option for FL/MZL.
The first-line treatment of rituximab can achieve a high disease control rate with tolerable adverse reactions, and the role of maintenance therapy cannot be ignored
.
Lenalidomide in combination with rituximab also offers patients an alternative strategy with similar efficacy to conventional chemotherapy
.
In FL and MZL, the recurrence rate was higher, and the survival of patients decreased significantly with the number of recurrences
.
However, there is still no standard treatment regimen for R/R FL/MZL
.
When a patient with iBCL is asymptomatic or the disease progresses slowly, it is necessary to decide whether to wait and watch under the doctor's advice in combination with the patient's comorbidities, psychosocial support, tumor location and size; if the disease progresses rapidly, histological transformation should be performed quickly Evaluate and choose an appropriate plan for active treatment
.
The high specificity and controllable safety of novel PI3K inhibitors have brought new hope to iBCL patients
.
HMPL-689, a highly selective small-molecule inhibitor targeting PI3Kδ, has shown promising antitumor activity and manageable efficacy in an ongoing Phase Ib clinical trial of monotherapy in patients with R/R lymphoma Safety, the ORR of 22 FL patients was 81.
8%, and the CR rate was 36.
4%; the clinical benefit rate (CBR) was 90.
9%; the ORR of 14 MZL patients was 50%, and the CBR was 100%3
.
It is believed that with the deepening of research, the "chemotherapy-free" regimen will bring survival benefits to more FL/MZL patients
.
At present, Chi-Med has conducted a multi-center, single-arm, open-label phase II clinical trial of "Evaluating the efficacy and safety of HMPL-689 in the treatment of patients with relapsed/refractory marginal zone lymphoma and follicular lymphoma" in several research centers in China.
Study" is in progress (Accession number: CTR20210264)
.
.
Follicular lymphoma (FL grades 1-3a) and marginal zone lymphoma (MZL) are two common iBCL subtypes
.
FL and MZL originate from lymphoid follicle center B cells and lymphoid follicle marginal zone, respectively
.
In recent years, with the continuous advent of new drugs and the continuous development of clinical diagnosis and treatment technology, the progression-free survival (PFS) of patients with FL/MZL has been prolonged, but some patients are faced with neutropenia and neutropenia caused by chemotherapy drugs.
The risk of infection, etc.
, reduces the compliance of patients with chemotherapy, and the curative effect is poor
.
Therefore, formulating a "chemotherapy-free" treatment plan with certain efficacy and high tolerance for FL/MZL patients who are not suitable for chemotherapy will help to improve the overall efficacy of FL/MZL treatment
.
On this occasion, Yimaitong sincerely invites Professor Feng Ru of Nanfang Hospital of Southern Medical University to share the current status of FL/MZL treatment and the progress of new drugs based on clinical experience and relevant literature
.
Standardize the treatment and management of FL/MZL disease and promote the overall improvement of the treatment level cure
.
② Asymptomatic advanced patients are usually followed up for observation and do not require treatment or can be given rituximab monotherapy
.
③ Patients with higher tumor burden are generally given rituximab-containing immunochemotherapy
.
02 "No chemotherapy" strategy: With the emergence of targeted drugs, iBCL patients with poor performance status are hopeful to obtain a targeted "no chemotherapy" treatment plan with certain efficacy and high tolerance
.
When clinicians choose a treatment plan for iBCL patients, they must first fully evaluate the patient's primary disease and physical condition
.
① A watch-and-wait strategy may be appropriate for asymptomatic patients with low tumor burden
.
② Comprehensive Geriatric Assessment (GA) can help guide decision-making, help doctors in-depth understanding of patient organ function, nutritional status, psychosocial factors, etc.
, and help predict patient survival, treatment discontinuation and hospitalization risk
.
③ When GA is not available, simple tools such as the Timed Up-and-Go (TUG) test can also be used to assess patient performance status
.
④ It is recommended that clinicians evaluate the functional status of iBCL patients and consider giving “no chemotherapy” regimen to frail patients
.
The first-line FL/MZL treatment plan has been optimized again, opening a new chapter in the first-line treatment of FL and MZL.
The first-line "chemotherapy-free" regimen currently mainly includes rituximab monotherapy, rituximab combined with lenalidomide (R2) regimen and radioimmunotherapy (see Figure 1)
.
Figure 1 Chemo-free strategies for first-line systemic therapy in FL or MZL (some strategies are used off-label in the United States) 1
.
(Note, this strategy comes from Thomas A Ollila et al Cancer Manag Res.
2021 May 14;13:3935-3952.
Recommended in the article) For FL patients with low tumor burden, rituximab monotherapy is the first-line treatment for FL/MZL Common scheme
.
Rituximab maintenance therapy was helpful in prolonging event-free survival (EFS), but there was no additional benefit from longer (5 years) maintenance therapy
.
Therefore, in the choice of regimen, the potential benefit of rituximab maintenance therapy should be weighed against the burden of long-term treatment and the associated risk of infection
.
Otuzumab, a type II glycoengineered humanized CD20 mAb, has shown good efficacy against iBCL in both relapsed/refractory and first-line therapy
.
The R2 regimen showed good antitumor activity in the treatment of FL and MZL
.
The SAKK 35/10 phase II study showed that the R2 regimen had an overall response rate (ORR) of 81% and a median PFS of 5 years, which was superior to rituximab monotherapy
.
In terms of safety, however, the R2 group had a higher rate of grade ≥3 adverse events (56% vs 22%) 1
.
Therefore, patients who expect a higher ORR or longer duration of remission may benefit from R2 therapy, but need to pay attention to the dose of lenalidomide and shorten its dosing time
.
A new exploration in the treatment of relapsed and refractory FL/MZL, the "chemotherapy-free" regimen is worth looking forward to.
The treatment regimen for patients with relapsed and refractory (R/R) FL/MZL should be based on the patient's symptoms, tumor burden, time to first remission, and intravenous administration.
The preference for drug or oral therapy determines the patient's next "chemotherapy-free" treatment strategy
.
Participation in a clinical trial is a possible option for eligible patients with poor performance status
.
Figure 2 FDA-approved chemotherapy-free strategy for the treatment of R/R FL/MZL (note that in the US, some regimens are used off-label for one or both histologic subtypes) 1
.
(This strategy comes from Thomas A Ollila et al Cancer Manag Res.
2021 May 14;13:3935-3952.
Recommended in the article) 01 Patients initially receiving rituximab monotherapy without maintenance therapy, 2 years after treatment Retreatment with rituximab may be acceptable in the event of disease progression above
.
02 For patients who can tolerate related adverse reactions, have not received first-line treatment with lenalidomide and have a creatinine clearance rate of >30mL/min, lenalidomide combined with anti-CD20 antibodies (rituximab/octuzumab) may provide an alternative treatment strategy
.
03 If the patient thinks it is troublesome to visit the infusion center frequently and wants to receive all-oral drug treatment, it is recommended to consider the following other treatment strategies ① Novel PI3K inhibitors: More specific PI3K inhibitors target the deregulated PI3K pathway, The latter is important for B cell receptor signaling, cell proliferation, and antitumor immunity
.
Currently, 4 PI3K inhibitors have been approved by the FDA for the treatment of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), follicular lymphoma and marginal zone lymphoma, namely Idelalisib, Copanlisib , Degrees Velise and Umbralisib
.
(Note: According to the information on GILD's official website, GILD has recently withdrawn the two indications of Idelalisib in the US market for recurrent FL and recurrent SLL due to the failure to complete the confirmation test required by the FDA
.
) The first-generation PI3Kδ inhibitor The patient's tolerance is poor, and common adverse reactions include infection, bone marrow suppression and inflammation (such as lung inflammation, colitis, etc.
)
.
HMPL-689 is a highly selective PI3Kδ inhibitor that highly targets PI3Kδ to reduce adverse effects resulting from inhibition of other isoforms
.
HMPL-689 has shown favorable efficacy and safety in preliminary results of its ongoing Phase Ib clinical study in Chinese R/R lymphoma patients
.
The study included 90 patients with R/R lymphoma with a median age of 57 years who received HMPL-689 30 mg daily
.
With a median follow-up of 5.
6 months, based on 76 patients with evaluable efficacy (22 in FL and 14 in MZL), the results showed that the median onset time was 1.
9 months (95%CI, 1.
84-1.
91); in the MZL subgroup, the median onset time was 1.
9 months.
In the FL subgroup, the ORR rate was 81.
8%, the CR rate was 36.
4%, the 1-year DOR rate was 59.
7% (95% CI, 15.
8-86.
6), and the 1-year PFS rate was 75.
8% (95%CI, 44.
8-90.
8)
.
The safety of the drug was manageable, and the most common grade 3 or higher treatment-related adverse events (TEAEs) in all patients were pneumonia (13.
3%) and neutropenia (11.
1%)
.
Liver and intestinal adverse reactions were mild, and AST and ALT were mildly to moderately increased in all patients (grade 1-2); the incidence of diarrhea was low, with 2.
2% of grade 3 or higher diarrhea
.
Permanent discontinuation due to AE was only 5.
6%3
.
Figure 3 Preliminary efficacy of MZL and FL patients 3 ② Ibrutinib BTK inhibitor monotherapy has not shown sufficient efficacy in FL
.
The ORR for ibrutinib in MZL was 58% (ORR was 81% for patients previously treated with rituximab alone), with a median PFS of 16 months and a median duration of response of 28 months
.
③ Tazemetostat Tazemetostat is an oral histone methyltransferase (EZH2) inhibitor, the mutation rate of EZH2 in FL is about 22%
.
In a phase II clinical trial, tazemetostat treated EZH2-mutant FL patients with an ORR of 69%, a CR rate of 13%, and a median PFS of 14 months; in EZH2 wild-type patients, ORR and CR rates were 35% and 4%, with a median PFS of 11 months
.
Tazemetostat may provide a valuable treatment option for FL patients who are candidates for Tazemetostat
.
04 Novel immunotherapy Novel immunotherapy strategies include antibody-drug conjugates (ADC), chimeric antigen receptor (CAR)-T cell therapy, bispecific antibodies, immune checkpoint inhibitors, etc.
, which have broad application prospects
.
① ADC Polatuzumab Vedotin (Pola) is an ADC targeting CD79b.
Among 20 FL patients receiving rituximab and Pola combination therapy, the ORR of the patients reached 70%, of which 45% achieved CR, and the median PFS was 15 months
.
The higher efficacy and controllable safety make the drug more suitable for elderly patients
.
② CAR-TCD19 CAR-T cells have significant curative effect in the treatment of iBCL patients
.
The ZUMA-5 phase II trial of akirenza injection enrolled patients with FL and MZL who had received ≥3 lines of therapy, had a performance status score of 0 or 1, and were up to 79 years old.
The results showed that the ORR of the patients was 92%, The CR rate was 76%
.
In terms of safety, 86% of patients experienced grade 3/4 adverse events
.
Analytical data from the Phase 2 ELARA study with a median follow-up of 17 months were presented at ASH2021
.
The results showed that the CD19 CAR-T cell therapy tisagenlecleucel was used to treat high-risk R/R FL patients, and among 94 patients with evaluable efficacy, the CR rate was 69.
1%, the ORR was 86.
2%, and the 12-month PFS was 67%
.
In terms of safety, cytokine release syndrome (CRS) occurred in 48.
5% of patients within 8 weeks of infusion, no patients experienced grade 3 or higher CRS, and 37.
1% experienced neurological events (3.
1% ≥ grade 3) , and there were no treatment-related deaths4
.
Although CAR-T cell therapy has high efficacy and potential curative effect, considering the intensity of lymphodepleting chemotherapy, the benefit/risk ratio of iBCL for the treatment of elderly or poor performance status remains to be determined
.
③ The bispecific antibody Mosunetuzumab is a CD20/CD3 bispecific antibody.
A total of 62 patients with FL were enrolled in a phase I trial for the treatment of R/R CD20-positive lymphoma.
The average age of the patients was 59 years old, and the highest age was 85 years old
.
The results showed that 68% of patients achieved remission and 50% achieved CR
.
Grade 3/4 treatment-related adverse events occurred in one-third of patients
.
Professor Feng Ru commented that both FL and MZL are common subtypes of indolent B-cell non-Hodgkin lymphoma with high heterogeneity
.
With the advent of new drugs, overall survival (OS) has improved in both diseases, and the overall survival of FL is close to 15 years5, but there are still some patients, especially those with disease progression within 24 months after first-line therapy (POD24) 6.
Facing the dilemma of refractory disease, recurrence, and poor prognosis; many FL/MZL patients are not suitable for high-intensity chemotherapy due to advanced age or comorbidities
.
It is very important to explore individualized "chemotherapy-free" regimens with high efficiency and low toxicity for such patients to reduce the risk of POD24, improve patient medication compliance, and improve patient survival and prognosis
.
"No chemotherapy" treatment has become a meaningful treatment option for FL/MZL.
The first-line treatment of rituximab can achieve a high disease control rate with tolerable adverse reactions, and the role of maintenance therapy cannot be ignored
.
Lenalidomide in combination with rituximab also offers patients an alternative strategy with similar efficacy to conventional chemotherapy
.
In FL and MZL, the recurrence rate was higher, and the survival of patients decreased significantly with the number of recurrences
.
However, there is still no standard treatment regimen for R/R FL/MZL
.
When a patient with iBCL is asymptomatic or the disease progresses slowly, it is necessary to decide whether to wait and watch under the doctor's advice in combination with the patient's comorbidities, psychosocial support, tumor location and size; if the disease progresses rapidly, histological transformation should be performed quickly Evaluate and choose an appropriate plan for active treatment
.
The high specificity and controllable safety of novel PI3K inhibitors have brought new hope to iBCL patients
.
HMPL-689, a highly selective small-molecule inhibitor targeting PI3Kδ, has shown promising antitumor activity and manageable efficacy in an ongoing Phase Ib clinical trial of monotherapy in patients with R/R lymphoma Safety, the ORR of 22 FL patients was 81.
8%, and the CR rate was 36.
4%; the clinical benefit rate (CBR) was 90.
9%; the ORR of 14 MZL patients was 50%, and the CBR was 100%3
.
It is believed that with the deepening of research, the "chemotherapy-free" regimen will bring survival benefits to more FL/MZL patients
.
At present, Chi-Med has conducted a multi-center, single-arm, open-label phase II clinical trial of "Evaluating the efficacy and safety of HMPL-689 in the treatment of patients with relapsed/refractory marginal zone lymphoma and follicular lymphoma" in several research centers in China.
Study" is in progress (Accession number: CTR20210264)
.
