Another EGFR-TKI curative effect was released!

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Summary:

1. Clin CANCER Res: New assisted chemical immunotherapy therapy for local advanced head and neck squamous cell carcinoma is safe and effective

2.J Thorac Oncol: SH-1028 Treatment of EGFR T790M Patients with Non-small Cell Cancer patients with good safety and safety

1

Clin CANCER Res: Neo -assisted chemical immunotherapy therapy for local advanced head and neck squamous cell carcinoma is safe and effective

▎ Clinical issue:

What is the antitumor activity and safety of neoaded chemotherapy combined with PD-1 inhibitory in the advanced advanced head and neck squamous cell carcinoma (HNSCC) patients?

A study from the CLIN CANCER RES magazine shows that the newly -auxiliary chemical immunotherapy therapy for local advanced HNSCC is safe and effective.

▎ Research plan:

A total of 30 patients were recruited for this single center, one -arm, and phase 2 test. For patients with resection III –IVB phase HNSCC, accepted chemotherapy on the first day of each 21 -day cycle [White protein combined with paclitaxel 260mg/m2 (or Dorcio 75mg/m2) plus Cisplatin 75mg/m2] and 200mg card The treatment of Ruilizumumab lasted for a total of 3 cycles, and then surgery and auxiliary radiotherapy. The common ultimate endpoint is pathology (PCR) rate and safety.

▎ Main discovery:

1) The objective relief rate (ORR) of 30 patients received patients with new assisted therapy was 96.7%(29/30).

2) 27 patients were not delayed for surgery, and the R0 resection rate was 92.6%(25/27). The clinical and pathological reduction rate is 100%(27/27). The PCR ratio was 37.0%(95%CI, 19.4%-57.6%), and the main pathological relief (MPR) rate was 74.1%(95%CI, 53.7%-88.9%).

3) The median follow-up time is 16.1 months (the range is 8.3-28.5 months), and the survival rate of no disease within 12 months is 95.8%(95%CI, 73.9%-99.4%).

4) Adverse events related to level 3 new assisted treatment include rash (1 case; 3.3%), itching (1 case; 3.3%), and platelet reduction (1 case; 3.3%), and not observed level 4 or level 5 level 5 Treatment of related adverse events. The most common surgical complications are delayed wound healing (5 cases; 18.5%).

▎ Looking out:

For local advanced HNSCC, neo -assisted chemotherapy combined with Karelizumab treatment shows high ORR, PCR and MPR rates, and its drug safety is acceptable. The above data supports the effect of further evaluation of new assisted chemical immunotherapy treatment for local advanced HNSCC.

references:

[1] ttps://aacjournals.org/Clincancerres/article/doi/10.1158/1078-0432.ccr-22-066/705058/neoadjuvant-chemmunotherapy--the-treatmet

2

J Thorac Oncol: SH-1028 Treatment of EGFR T790M Patients with Positive Non-Cell Cancer patients with good safety and safety

▎ Clinical issue:

SH-1028 is a new type of EGFR-TKI, which is now used to develop non-small cell lung cancer (NSCLC) patients who treat EGFR and EGFR T790M sensitive mutations. The effectiveness and safety of the SH-1028 treatment of EGFR T790M positive NSCLC patients are currently unclear.

A phase 2 clinical trial from J Thorac Oncol shows that the effectiveness and safety of the SH-1028 treatment of EGFR T790M positive NSCLC patients.

▎ Research plan:

This study is a multi -centered, single -arm, and open label 2 phase of clinical trials. The entry standard of the subject is that it needs to be diagnosed by the medical center to be diagnosed with advanced NSCLC patients with EGFR T790M mutations, and it has progressed after using the first or second -generation EGFR TKIS, or a primitive EGFR T790M mutation. The subject was taken orally in the study SH-1028 tablets, and the dose was 200 mg/day. According to RECIST 1.1, the clinical efficacy of tumor treatment is evaluated every 6 weeks. The main endpoint of this study is an objective relief rate (ORR) evaluated by the Independent Examination Committee (IRC). The secondary end point is no progressive survival (PFS), total survival (OS), disease control rate (DCR), and safety.

▎ Main discovery:

(1) In this study, a total of 286 EGFR T790M positive advanced NSCLC patients were entered, of which 59 were in part A (dose verification research) and 227 people in part B (second -line registration).

(2) Statistics as of September 17, 2021, parts A and B subjects were 55.9%(95%CI 42.4%-68.8%) and 60.4%(95%CI 53.7%) evaluated by IRC, respectively. -66.8%). The median PFS of the subject A is 12.4 months (95%CI 8.3-20.8 months), and part B is 12.6 months (95%CI 9.7-15.3 months). Part A's median OS is 26.0 months (95%CI 23.3-NR months), and the relevant data of part of the subjects of part B is temporarily lacking. (3) Of the 286 subjects, 44 people experienced at least once 3 or more treatment -related adverse events (TRE), the most common of which was elevated serum civilease level [13 (4.5%)] , Diarrhea [6 (2.1%)] and QT extension [3 (1.0%)]. 26 (9.1%) subjects reported rash related to treatment, and these bad events were level 1 or 2. This study did not report to the occurrence of intermediate lung disease.

▎ Looking out:

SH-1028 The effectiveness and tolerance of patients with EGFR T790M positive NSCLC patients may be used as a second-line treatment of second-line therapy for this patient group.

references:

[1] https://www.jto.org/article/s1556-0864 (22) 00327-6/FullText

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