For the nation, anti-tumor article takes stock of the 2021 Anlotinib & Paimrizumab blockbuster study (part 1)

*Only for medical professionals to read for reference.
Quickly check in five major areas of lung cancer, hematological tumors, thyroid cancer, sarcoma, and basic research! Chia Tai Tianqing has formed a unique product line in the field of anti-tumor-the new class 1.
1 drug Anlotinib is China's first approved third-line treatment for advanced non-small cell lung cancer (NSCLC) and the first approved soft tissue sarcoma in China , Small cell lung cancer (SCLC), targeted drugs for medullary thyroid cancer
.

Paimrizumab, which is also a new class of drug, is the only new PD-1 inhibitor that uses IgG1 subtype and is modified by the Fc segment among the products currently on the market.
It has been approved for relapse after at least second-line system chemotherapy.
Or the indications for adult patients with refractory classic Hodgkin's lymphoma
.

 In 2021, Anlotinib and Paimrizumab will continue to work hard, and they will shine on the track of various tumor types.
As a representative of China’s original innovative drugs, they will deliver the "Voice of China" at various international conferences.
A total of more than 100 studies were selected at the American Society of Clinical Oncology (ASCO) Conference and the European Society of Medical Oncology (ESMO) Annual Conference, and dozens of other studies were published in top oncology journals such as Journal of Thoracic Oncology and Clinical Cancer Research
.

 Anlotinib and Paimrizumab precipitate the results of clinical research and become a powerful "weapon" for oncologists.
They also "escort" the longer and better survival of Chinese cancer patients and help achieve "Healthy China 2030" "The ultimate goal
.

This article summarizes the blockbuster clinical studies of Anlotinib and Paimrizumab in the fields of lung cancer, hematological tumors, sarcoma, thyroid cancer, and basic research in 2021
.

The field of lung cancer covers NSCLC&SCLC, illuminating the light of life for lung cancer patients▌ The strong will stay strong and explore the infinite possibilities of NSCLC treatment 1.
Paimrizumab combined with paclitaxel and carboplatin compared with placebo combined with paclitaxel and carboplatin in the first-line treatment of metastatic squamous cells Symptoms of NSCLC: Randomized, double-blind, multi-center phase Ⅲ clinical research review: The median progression-free survival (PFS) of Paimrizumab combined with chemotherapy and chemotherapy alone was 7.
0 months (95%CI, 5.
6) -9.
7) vs 4.
2 months (95%CI, 4.
2-4.
3, HR=0.
40, p<0.
00001), objective response rates (ORR) were 69.
7% vs 43.
4% (p<0.
00001), median duration of response ( DoR) were 9.
43 months vs.
2.
96 months
.

The incidence of all grades of immune-related adverse reactions (irAE) in the group of Paimrizumab combined with Anlotinib was 19.
7%, and the incidence of grade ≥3 irAE was 2.
9%; research value: Paclitaxel plus Paclitaxel Carboplatin is expected to become a new choice for the first-line treatment of advanced squamous NSCLC
.

Based on this research, Chia Tai Tianqing & Kangfang Biology has submitted an application for the first-line indication for advanced squamous NSCLC to the National Medical Products Administration (NMPA) and has been accepted
.

 2.
A review of clinical studies on the first-line treatment of Pianprizumab combined with Anlotinib for advanced non-squamous NSCLC: As of January 13, 2021, 26 patients have been enrolled, with a median treatment time of 3.
5 months
.

21 patients can be evaluated for efficacy, ORR is 57.
1%, disease control rate (DCR) is 90.
5%
.

Among the 26 patients, the incidence of all treatment-related adverse events (TRAE) was 53.
8%, and the incidence of grade 3 or higher was 15.
4%.
The incidence of suspension and discontinuation due to TRAE was 7.
7%
.

Research value: Peripolizumab combined with Anlotinib as the first-line treatment of locally advanced/metastatic NSCLC has shown good efficacy and manageable safety, thus indicating that the combination therapy may be a locally advanced/metastatic NSCLC patient A feasible "chemo-free" treatment strategy
.

  3.
A prospective study of anlotinib-based combination therapy in the first-line treatment of advanced NSCLC (ACTION study): a three-arm prospective study review: cohort A (anlotinib combined with erlotinib) ORR was 92.
9 % (95% CI, 76.
5-99.
1), DCR was 96.
4% (95% CI, 81.
7-99.
9); cohort B (anlotinib combined with pemetrexed or gemcitabine and carboplatin) ORR was 60.
0% (95% CI, 40.
6-77.
3), DCR is 96.
7% (95% CI, 82.
8-99.
9)
.

The median PFS of cohort A was 21.
6 months, and the 24-month overall survival (OS) rate was 87.
1%; the median PFS of cohort B was 13.
3 months, and the median OS was 28.
1 months; cohort C (anlotinib combined letter Dilimumab) median PFS was 15.
6 months, and the 24-month OS rate was 83.
9%
.

Research value: Anlotinib-based combination program is expected to become a new choice for the first-line treatment of advanced NSCLC
.

  4.
Anlotinib combined with sintilizumab in the first-line treatment of advanced NSCLC patients phase Ib study review: this study enrolled 22 patients, of which 16 patients achieved confirmed partial remission (PR), ORR was 72.
7% (95%CI, 49.
8%-89.
3%), DCR is 100% (95%CI, 84.
6%-100%)
.

The median PFS was 15 months (95% CI, 8.
3-not reached), and the 12-month PFS rate was 71.
4% (95% CI, 47.
2%-86.
0%).
Research value: This study is the first to evaluate PD-1 inhibitors Combination of multi-target anti-angiogenic TKI for the first-line treatment of NSCLC patients
.

In view of its encouraging efficacy, durability and safety characteristics, anlotinib combined with sintilimab may become a new "chemo-free" option for this patient.
This study was also published in the Journal of Thoracic Oncology magazine (IF:15.
6)
.

   5.
Anlotinib combined with icotinib in the first-line treatment of patients with EGFR-sensitive mutations in NSCLC: ALTER-L004 results update study review: the median PFS of evaluable patients was 15.
1 months (95%Cl: 11.
3-18.
9), ORR was 67.
9%, and DCR was 98.
2%
.

58.
9% of patients had tumor shrinkage ≥30% at the first evaluation of efficacy
.

The median PFS of patients with EGFR co-mutation and EGFR pathogenic co-mutation were 15.
6 months (95% Cl: 10.
4-20.
8) and 14.
9 months (95% Cl: 9.
1-20.
7), respectively
.

Research value: This latest analysis confirms that anlotinib combined with icotinib has shown encouraging effects on untreated patients with advanced NSCLC with EGFR mutations, and may provide a solution for patients with EGFR co-mutated NSCLC New treatment options
.


6.
A review of clinical research studies of Anlotinib combined with Gefitinib in the first-line treatment of EGFR-mutant advanced NSCLC: As of March 18, 2021, a total of 21 patients were enrolled
.

13 patients achieved PR, 8 patients achieved stable disease (SD), ORR was 61.
9%, DCR was 100%, and median PFS was not reached
.

Ten of the 13 Del19 mutation patients (77%) achieved PR, and 3 of the 8 L858R mutation patients (38%) achieved PR
.

Research value: The combination of anlotinib and gefitinib in the treatment of previously untreated EGFR mutation-positive advanced NSCLC shows good efficacy and safety
.


7.
A review of a single-arm multicenter phase II clinical study of anlotinib monotherapy in elderly patients with non-squamous NSCLC without systemic chemotherapy: median PFS was 5.
2 months (95% Cl: 2.
8-7.
6), medium The bit OS was not reached, and the DCR was 89.
5% (17/19)
.

Research value: Anlotinib has shown potential efficacy and good tolerability in the treatment of advanced non-squamous NSCLC over 70 years old who have not received systemic chemotherapy in the past
.

 8.
TQ-B2450±Anlotinib in the treatment of NSCLC that has failed chemotherapy: A review of multicenter, randomized, double-blind clinical studies: The median PFS of the TQ-B2450 combined with Anlotinib group and the TQ-B2450 group were respectively 6.
9 months vs 2.
7 months (HR 0.
43, P=0.
0014), ORR was 30.
9% vs 3.
0% (P=0.
0043), DCR was 73.
5% vs 54.
6% (P=0.
1620) Research value: TQ-B2450 combination Anlotinib may be a promising treatment for advanced NSCLC patients who have received systemic treatment in the past
.

A randomized, controlled phase III clinical study of TQ-B2450 combined with anlotinib versus pembrolizumab in the first-line treatment of advanced NSCLC patients with PD-L1≥1% is currently underway (NCT04964479)
.

  9.
Anlotinib combined with docetaxel vs.
Docetaxel in the second-line treatment of EGFR wild-type advanced NSCLC randomized phase II clinical study (ALTER-L018) review: Group A (anlotinib combined with docetaxel ) The median PFS was 4.
26 months (95% Cl: 2.
82-5.
70), and the median PFS of group D (receiving only docetaxel) was 1.
64 months (95% Cl: 0.
00-3.
29, HR 0.
31, 95% Cl) ：0.
17-0.
59, p<0.
001)
.

The median OS in group A was 16.
16 months (95% Cl: 2.
98-29.
34), and the median OS in group D was 10.
85 months (95% Cl: 5.
78-15.
92, HR 0.
97, 95% Cl: 0.
48-2.
00; p= 0.
943)
.

Research value: Anlotinib combined with docetaxel is a viable option for advanced NSCLC that has failed first-line platinum-containing chemotherapy.
It can significantly prolong PFS with controllable adverse reactions
.

   10.
Anlotinib combined with docetaxel vs.
docetaxel in the second-line treatment of advanced NSCLC I/II study update results Research review: the median of anlotinib + docetaxel group and docetaxel group PFS was 6.
5 months vs 2.
7 months (HR=0.
30, p=0.
004); among 46 evaluable patients, ORR was 21.
9% vs 14.
3% (p=0.
70), and DCR was 100.
0% vs 57.
1% (p< 0.
001)
.

Research value: Anlotinib combined with docetaxel continues to show good efficacy and safety in advanced NSCLC patients who have progressed after platinum-based chemotherapy.
Anlotinib combined with docetaxel may become advanced A new option for second-line treatment of NSCLC
.


11.
Efficacy and safety of anlotinib combined with docetaxel in the treatment of advanced NSCLC that has failed the previous immune checkpoint PD-1 inhibitor treatment: a review of the results of a phase I/II study: median PFS in enrolled patients It was 7.
6 months (95% CI, 1.
56-13.
65), ORR was 42.
9%, and DCR was 100%
.

Research value: Anlotinib combined with docetaxel has shown clinically significant efficacy and manageable safety in advanced NSCLC patients who have previously received immune checkpoint PD-1 inhibitor (ICls) treatment failure.
It may provide a better treatment option for advanced NSCLC patients who have failed previous front-line ICIs treatment
.


12.
Anlotinib combined with TQB2450 injection for the treatment of advanced NSCLC with EGFR mutations and EGFR-TKI treatment failure: A review of multi-center, single-arm clinical studies: Among evaluable patients (n = 18), ORR was 11.
1%, The DCR was 77.
8%, and the median PFS was 8.
0 months (95% CI 4.
9-11.
1)
.

Research value: TQ-B2450 combined with Anlotinib's "chemo-free" model for the treatment of EGFR mutation-positive advanced NSCLC patients who have failed previous EGFR-TKI therapy shows promising anti-tumor efficacy and good safety
.


13.
A review of clinical research studies of Anlotinib combined with PD-1 inhibitors in the treatment of advanced NSCLC: From March 2019 to April 2021, a total of 19 patients were enrolled
.

After 8 weeks of PD-1 inhibitor monotherapy, ORR was 26.
3% and DCR was 68.
4%
.

During PD-1 inhibitor combined with Anlotinib treatment, ORR was 68.
4%, DCR was 89.
5%, and overall median PFS was 13.
1 months (95% CI, 8.
6-14.
9)
.

Research value: Anlotinib combined with PD-1 inhibitors has initially shown encouraging efficacy and good safety in the second-line and above treatment of advanced NSCLC
.

 14.
Efficacy and safety of anlotinib combined with PD-1 inhibitors in patients with advanced NSCLC after the failure of previous systemic therapy-a retrospective study review: 19 patients with PR (28.
4%), 39 patients with SD (58.
2) %), 9 patients had disease progression (PD) (13.
4%)
.

ORR and DCR were 28.
4% and 86.
6%, respectively
.

The median PFS was 6.
9 months (95%CI, 5.
5-8.
3), and the median OS was 14.
5 months (95%CI, 10.
9-18.
1)
.

Research value: In patients with advanced NSCLC who have previously received treatment, PD-1 inhibitor therapy combined with Anlotinib has tolerable toxicity and good anti-tumor activity
.

The results of this study support the benefits of combination therapy with immune checkpoint inhibitors and anti-angiogenic drugs
.

Since no additional toxicity was observed in the combination therapy, the combination therapy can be further evaluated with or without chemotherapy
.

  15.
The occurrence of hypertension during the third-line treatment of anlotinib in advanced NSCLC is associated with the prognosis of patients with squamous cell lung cancer (SCC): A review of the post-analysis study of the ALTER0303 trial: The median PFS of patients with hypertension was longer than that of patients without hypertension [ 7.
2 (95%CI, 3.
5-11.
0) and 3.
2 (95%CI, 1.
2-5.
3) months, p=0.
001; HR (95%CI), 0.
4 (0.
2-0.
8)]
.

Among patients with an ECOG score of 0, the median PFS of patients with hypertension and those without hypertension were 5.
6 months and 1.
8 months, respectively
.

Among patients with an ECOG score of 1, the median PFS of patients with hypertension and those without hypertension were 7.
0 (95%CI, 3.
0-11.
0) and 4.
8 (95%CI, 1.
2-8.
5) months, respectively (p = 0.
043)
.

Research value: The occurrence of hypertension may be a clinical indicator predicting the efficacy of anlotinib in the third-line treatment of SCC patients
.

 16.
Anlotinib combined with osimertinib in NSCLC through the FGFR and EGFR signaling pathways to overcome osimertinib acquired resistance research review: compared with anlotinib or osimertinib alone, anlotinib The combination of osimertinib and osimertinib can more effectively inhibit the proliferation and migration of two drug-resistant osimertinib cell lines
.

The CI value proved the synergistic effect of Anlotinib combined with Osimertinib
.

Western blot analysis showed that the combined regimen can effectively inhibit the phosphorylation of EGFR and FGFR, and then down-regulate the phosphorylation level of Akt/Erk
.

Research value: Therefore, FGFR overexpression may be the mechanism of osimertinib acquired resistance
.

Anlotinib combined with osimertinib can overcome osimertinib resistance by inhibiting EGFR and FGFR signaling pathways
.

Two-pronged "sword-finger" SCLC first-line treatment 17.
Anlotinib combined with etoposide + cisplatin/carboplatin (EP/EC) first-line treatment for extensive-stage SCLC: Final results from a phase II single-arm study review: 2019 From January 2008 to August 2020, a total of 20 patients with extensive-stage SCLC were enrolled.
The median PFS was 10 months (95%Cl 7.
81-12.
19), and the median OS was 15 months (95%Cl 10.
64-19.
36).
Among them, 1 case was complete remission (CR), 17 cases were PR, 2 cases were SD, ORR was 90%, and DCR was 100%
.

Research value: Anlotinib combined with EP/EC has better PFS, OS, ORR and DCR in the initial treatment of extensive-stage SCLC, and the adverse reactions are controllable
.

  18.
Review of the SCLC study of Paimrizumab combined with Anlotinib in the second-line treatment of platinum-based chemotherapy: 21 cases of SCLC patients who had progressed from platinum-based chemotherapy were enrolled.
The ORR was 42.
86%, and the DCR was 71.
43%, with a median.
The PFS is 4.
62 months
.

Research value: Paimrizumab combined with Anlotinib has shown good anti-tumor activity and acceptable safety in SCLC patients who have failed platinum-based system chemotherapy.
This new combination therapy for the treatment of SCLC deserves further Assessment
.

   19.
Anlotinib combined with irinotecan/docetaxel in the treatment of SCLC relapsed within 6 months: Phase II study update results Study review: The median PFS of the patient was 4.
0 months (95% Cl: 3.
16-4.
84), The median OS was 7.
5 months (95% C: 3.
01-11.
99)
.

Among the 21 evaluable patients, 1 CR, 9 PR, ORR was 47.
6%, and DCR was 90.
5%
.

Research value: In SCLC that relapses within 6 months after first-line platinum-based chemotherapy treatment, Anlotinib combined with irinotecan or docetaxel continues to show promising efficacy and controllable toxicity.
This combined treatment mode May become a new treatment strategy
.


20.
Anlotinib vs.
placebo as the third-line and above treatment for SCLC patients: A review of a randomized, double-blind, placebo-controlled phase II study: The median PFS of the anlotinib group was significantly longer than that of the placebo group ( 4.
1 months vs 0.
7 months, HR 0.
19, p<0.
0001)
.

The OS of the Anlotinib group was significantly longer than that of the placebo group (7.
3 months vs 4.
9 months, HR 0.
53, p=0.
0029)
.

Research value: Compared with placebo, Anlotinib, as a third-line or follow-up treatment for Chinese SCLC patients, significantly improves PFS and OS, and has good safety
.


21.
The effect of previous chest radiotherapy on the prognosis of recurrent SCLC patients treated with Anlotinib: A review of the subgroup analysis of the ALTER 1202 trial: In radiotherapy (RT) (5.
49 vs.
0.
69 months; P <0.
001) and non- In the RT (2.
83 vs.
0.
76 months; P<0.
001) subgroup, the PFS of the anlotinib group was longer than that of the placebo group
.

In the RT subgroup, the OS of the anlotinib group was longer than that of the placebo group (9.
49 vs.
4.
90 months; P=0.
039)
.

No difference in ORR was found, but in the RT subgroup (73.
9% vs.
9.
1%, P<0.
001) and the non-RT subgroup (68.
6% vs.
18.
8%; P = 0.
002), the DCR of the anlotinib group was higher In the placebo group
.

Research value: In patients with recurrent SCLC who have previously received chest RT, Anlotinib may have DCR, PFS, and OS benefits compared with placebo
.

In patients who have not previously received chest RT, anlotinib may have DCR and PFS benefits compared to placebo
.

The safety of anlotinib group and placebo group is similar
.

Basic research and innovative dual synergistic mechanism, bringing unlimited potential 22.
Research review and value of the structural characteristics of Paimrizumab: Paimrizumab is a modified Fc-segment IgG1 subtype PD-1 inhibitor It removes the multiple effector functions mediated by the Fc segment of the antibody (including ADCC, ADCP and CDC), and reduces the release of IL-6 and IL-8; it can interact with the N-58 glycosylation site of human PD-1 Point-to-point combination to obtain strong T cell activation activity by permanently blocking the PD-1/PD-L1 pathway
.

  23.
Review and value of the research on the synergistic mechanism of Anlotinib and Paimrizumab: The combined use of Anlotinib and Paimrizumab significantly reduces the density of blood vessels in the tumor, improves the morphology of tumor blood vessels, and reduces blood vessels Budding and regenerating, reduce the level of hypoxia in the tumor; combined with Anlotinib can significantly increase the distribution of Peamprizumab in the tumor; the proportion of TIM3+PD1+CD8+T cells in the combined group is reduced, and T cells are in the tumor at the same time Increased internal infiltration
.

This study provides a strong scientific basis for the combination therapy of Anlotinib and Paimrizumab to improve the tumor microenvironment and immunotherapy, highlighting the clinical potential of this new combination therapy
.

  24.
The population pharmacokinetics (PopPK) of Paimrizumab (PopPK) Research Review & Value: The PopPK model fully evaluates the PK characteristics and influencing factors of Paimrizumab in hematological tumors and solid tumors
.

The simulation results show that both weight-based administration and fixed-dose administration (200 mg Q2W or Q3W) of Pianprizumab are feasible
.

  Structural optimization and strong safety in the field of hematological tumors, creating a new future for hematological tumor treatment 25.
A phase II study of Pianprizumab in the treatment of patients with relapsed or refractory (R/R) classic Hodgkin’s lymphoma (cHL) Review of the study: After a median follow-up of 15.
8 months, the ORR of the treatment with periprizumab was as high as 89.
4%, and the CR rate was 47.
1%
.

The median PFS has not yet been reached, and the PFS rate at 12 months is 72.
1%; the OS rate at 18 months is 100%; the median DoR has not yet been reached
.

The incidence of ≥ grade 3 TRAEs was 26.
6%, and the incidence of grade 3 immunotherapy-related adverse events (irAEs) was only 4.
3%.
No CTCAE grade 4 or 5 irAEs were observed
.

 Research value: Pianprizumab has a better response rate in R/R cHL patients
.


26.
Based on the population PK model and exposure-response (ER) analysis, a review of the dose selection study of periprizumab in the R/R cHL population: more than 97.
5% of patients, regardless of the use of 200mg Q2W, 200mg Q3W, or 400mg Q6W administration, its steady-state trough blood concentration> 3μg/mL, far exceeding the concentration required to achieve 90-100% PD-1 receptor occupancy (0.
5 μg/mL); and under the 400mg Q6W dosing schedule The peak concentration and AUCss are lower than the corresponding concentration of the maximum actual dose (10mg/kg) in the current clinical trials
.

In the study of cHL, the main pharmacokinetic parameters (Cmax, ss, Cmin, ss, AUC, ss) and various efficacy indicators (DCR, ORR and CR) and various safety indicators (≥3 Grade TRAE, Grade ≥3 irAE, AE leading to discontinuation) did not have a significant correlation
.

 Research value: PopPK simulation and ER analysis results show that both weight-based administration and fixed-dose administration (200 mg Q2w, 200 mg Q3W or 400 mg Q6W) are suitable for Pianprizumab
.

  The field of thyroid cancer breaks the dilemma of refractory thyroid treatment, and innovates the treatment thinking and pattern.
27.
Anlotinib in the treatment of radioiodine-refractory differentiated thyroid cancer (RAIR-DTC): A review of the subgroup analysis based on the ALTER01032 study: The Asia Group analysis results showed that patients with poor baseline characteristics showed a higher risk of progression and death
.

In all subgroups, patients who received anlotinib had significantly longer PFS than those who received placebo (P <0.
05)
.

In patients with bone metastases or disease progression within 3 months, Anlotinib treatment achieved significant OS benefits (P<0.
05)
.

In addition, in elderly patients, a trend of improvement in OS was observed (HR=0.
85, 95%CI, 0.
37-1.
97)
.

Most patients in the placebo group received crossover treatment.
After adjustment, compared with patients receiving placebo, the risk of death was almost significantly reduced in elderly patients receiving anlotinib (HR=0.
48, 95%CI, 0.
20-1.
13)
.

Research value: This subgroup analysis showed that the PFS and OS of RAIR-DTC patients with poor baseline characteristics were effectively improved
.

It is worth noting that although most patients in the placebo group received cross-anlotinib, their risk of death was still higher, indicating the importance of early treatment for these patients
.


28.
A review of the randomized, double-blind phase IIb study of Anlotinib in the treatment of metastatic or refractory medullary thyroid carcinoma (MTC): The median PFS of the Anlotinib group was significantly longer than that of the placebo group (20.
7 months vs.
.
11.
1 months, P=0.
029; HR, 0.
53; 95% CI, 0.
30-0.
95)
.

The ORR of anlotinib treatment was 48.
4%
.

The incidence of TRAE in the anlotinib group and placebo group was 100% and 89.
7%, respectively
.

Research value: Anlotinib has proven its efficacy and safety in this phase IIB trial for the treatment of MTC, and may become a new choice for this rare disease, especially for Chinese patients
.


29.
A review of a single-arm phase II clinical trial study on the efficacy and safety of anlotinib neoadjuvant treatment of locally advanced thyroid cancer: The ORR of anlotinib is 76.
9% (95% CI, 46.
2%-95.
0%)
.

The R0/R1 resection rate of the intention-to-treat population was 61.
5%, that of the population meeting the protocol was 72.
7%, and the 18-week DCR rate was 92.
3%
.

Research value: Anlotinib shows anti-tumor activity in neoadjuvant therapy, and most patients achieve R0/R1 resection, suggesting that anlotinib neoadjuvant therapy may become a new option for locally advanced thyroid cancer
.

In the field of sarcoma, Anlotinib reverses the treatment decline and achieves dual benefits of efficacy and function.
30.
A review of the Phase III study of Anlotinib as a single agent in the treatment of advanced/metastatic synovial sarcoma (SS): A total of 79 patients began to receive treatment and Evaluable, 52 patients received Anlotinib as the treatment group (T) and 27 patients received Dacarbazine as the control group (C)
.

The median PFS of the anlotinib group was 2.
89 months (95% Cl: 2.
73-6.
87), and the median PFS of the control group was 1.
64 months (95% Cl: 1.
45-2.
70), the p value was 0.
0015, and the HR was 0.
449 (95% Cl: 0.
270- 0.
744)
.

In the 4th, 6th, and 12th months, the percentages of PFS patients in the Anlotinib group were 48.
1%, 42.
3%, and 26.
9%, respectively, and the control group was 14.
85%, 11.
1%, and 3.
7%
.

Research value: This phase III trial shows that in patients with advanced SS, Anlotinib has improved disease control and PFS is better than dacarbazine
.

  31.
Epirubicin combined with anlotinib followed by anlotinib in the first-line treatment of advanced soft tissue sarcoma single-arm phase II clinical research review: the main subtypes of the enrolled patients were 10 cases of leiomyosarcoma, 8 cases of fibrosarcoma, no There were 5 cases of differentiated liposarcoma, 4 cases of SS, 2 cases of undifferentiated pleomorphic sarcoma, and epithelioid sarcoma
.

The 12-week PFS rate, 6-month PFS rate, ORR, and DCR were 70%, 53.
8%, 13.
3%, and 80%, respectively
.

The median PFS was 11.
5 months (95% Cl: 5.
0-NA), and the median OS had not yet been reached
.

Research value: Patients with unresectable advanced soft tissue sarcoma can benefit from the first-line treatment of epirubicin combined with anlotinib
.

And Anlotinib is generally well tolerated, especially without short-term cardiotoxicity
.

  32.
Anlotinib combined with liposomal adriamycin in the first-line treatment of soft tissue sarcoma research review: 2 patients (25%) obtained PR and 3 patients (37.
5%) SD
.

ORR and DCR were 25% and 62.
5%, respectively, and the median PFS was 11.
3 months
.

Research value: Anlotinib combined with liposomal adriamycin may have anti-tumor activity and acceptable toxicity in the first-line treatment of patients with advanced soft tissue sarcoma
.

   33.
Retrospective study review of anlotinib combined with adriamycin and ifosfamide (AI) neoadjuvant treatment of unresectable soft tissue sarcoma: the results of the efficacy evaluation showed that the best PR of the enrolled patients was 8 cases (28.
57%) , The best SD was 8 cases (20/28, 71.
43%)
.

ORR and DCR were 28.
57% and 100.
0%, respectively.
The tumor regression of SS and myxoid liposarcoma (MLPS) was significantly better than that of fibrosarcoma (FS) (p=0.
012, p=0.
042)
.

In the end, 24 patients underwent surgery, including R0 resection in 19 cases, R2 resection in 3 cases, and amputation in 2 cases
.

The rates of limb salvage and R0 resection were 91.
67% (22/24) and 79.
17% (19/24), respectively
.

The median PFS was 21 months (95% Cl: 8.
53-33.
69 months)
.

Research value: Anlotinib+Al can be used as an alternative treatment strategy for unresectable soft tissue sarcoma
.

  34.
A review of the Phase II study of Anlotinib in the first-line treatment of locally advanced or metastatic soft tissue sarcoma: 26 patients were able to assess tumor remission, 1 obtained PR, ORR was 3.
85% (1/26), SD was 24 cases, and DCR was 96.
2% (25/26)
.

The clinical benefit rate (CBR) is defined as the proportion of patients who have achieved continuous disease control (CR/PR/SD) for more than 4 months and 6 months, respectively, 65.
4% (17/26) and 38.
5% (10/26)
.

Research value: Anlotinib has good efficacy and tolerability in the first-line treatment of locally advanced or metastatic soft tissue sarcoma
.

  35.
Retrospective study of Anlotinib in the treatment of relapsed and refractory advanced solid tumors in children: 41 patients and 30 patients were enrolled in the study, and the efficacy and safety were evaluated respectively
.

The ORR was 12.
2% (95% CI, 1.
7-81), and the median PFS was 2.
87 months (95% CI, 0.
86-4.
88)
.

Research value: For relapsed/refractory solid tumors in children, Anlotinib may be an effective treatment with tolerable adverse events, and further prospective randomized controlled clinical studies are necessary
.

   36.
A review of the multicenter phase Ib study of Anlotinib combined with TQB2450 in the treatment of advanced soft tissue sarcoma: The ORR of the enrolled patients was 36.
7%, the DCR was 83.
3%, and 11/30 cases achieved PR
.

4/30 cases (46.
7%) were SD, and 5/30 cases (16.
7%) were PD
.

The median PFS of all patients was 9.
6 months
.

It is worth noting that the ORR of patients with alveolar soft tissue sarcoma (ASPS) is 75%, and the DCR is 100%
.

Research value: Anlotinib and TQB2450 are used in the second-line treatment of advanced soft tissue sarcoma, especially ASPS, with good tolerability and acceptable toxicity
.

   37.
Anlotinib combined with TQB2450 in the treatment of advanced soft tissue sarcoma multi-center phase Ib study-updated data after sample size expansion study review: tumor remission was observed in 23 patients, the total ORR was 48.
9%
.

16 patients had SD, lasting at least 4 weeks, and the DCR was 83%
.

The ORR of ASPS patients was as high as 72.
4%, and the DCR was 96.
6%
.

The overall median PFS was 8.
97 months (95% Cl: 5.
33-12.
61)
.

Research value: The updated results further prove the efficacy of anlotinib combined with TQB2450 in the treatment of advanced soft tissue sarcoma, and regardless of its histological type, ASPS patients have obtained more impressive survival benefits and tumor remission
.


38.
A review of the study of preoperative radiotherapy with Anlotinib for non-metastatic limb and trunk soft tissue sarcoma: 8 patients (8/16, 50%) and 8 patients who achieved PR and SD one month after the end of radiotherapy , DCR is 100%
.

All patients with PR had significant tumor shrinkage during the first 1 to 2 weeks of the radiotherapy period
.

According to the EORTC-STBSG standard, 2 cases achieved complete pathological remission (no surviving tumor cells)
.

The 11 patients with unresectable or borderline resectable tumors were all non-R2 limb salvage extensive resections, with R0 in 9 cases and R1 in only 2 cases
.

Research value: For patients with non-metastatic primary sarcoma of the limbs or trunk, Anlotinib combined with preoperative radiotherapy is safe, well tolerated, and has good clinical and pathological responses
.

The early remission after the addition of Anlotinib allows more patients with unresectable or marginal resectable tumors to be completely removed by extremity salvage surgery
.


39.
Anlotinib combined with vincristine and irinotecan (AVI) in the treatment of advanced Ewing's sarcoma that failed first-line chemotherapy.
A review of clinical research studies: In the A cohort (≥16 years old) of the 24 patients in the Il stage, 23 Patients can be evaluated for efficacy at 12 weeks, including 1 case of CR, 14 cases of PR, 2 cases of SD, and 6 cases of PD.
The ORR at 12 weeks was 62.
5%
.

In cohort B (<16 years old), there were 4 CRs, 6 PRs, and 2 PDs.
The ORR at 12 weeks was 83.
3%
.

Research value: The combined treatment of vincristine, irinotecan and anlotinib shows acceptable toxicity characteristics and promising clinical efficacy in patients with advanced Ewing's sarcoma
.


As a pioneer of China's national pharmaceutical companies, Chia Tai Tianqing has been adhering to the original intention of "anti-tumor for the nation", and strives to bring higher-quality independent and innovative anti-tumor drugs to cancer patients in China and the world, such as Anlotinib and Paian Pritimab has changed the treatment outcome of countless cancer patients and brought them hope for life; it has provided clinicians engaged in tumor treatment with a powerful weapon, giving them the ability and confidence to break through various treatment problems; Inject lasting new vitality, successfully promote the development of the field, and change the treatment pattern
.

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