Several PD-1/PD-L1 cortable injections are not intravenously administered.

Immunotherapy, especially PD-1/PD-L1 antibodies, has become a hot spot in anti-tumor treatment in recent years, and the currently listed PD-1/PD-L1 antibodies have been approved for the treatment of a variety of tumors, but all are intravenous administration, that is, drip-drip way of administration.
risks of using immunologic drugs in the veins, which can lead to rapid hypothermia, imbalance of electrolytes in the blood, and more likely blood clots.
intravenously must therefore be treated with the help of a specialist nurse in a medical institution.
patients need to go to the hospital every time infusion, which will always take a lot of time and inconvenient.
in order to shorten treatment time, save healthcare resources, facilitate patients and make patients more acceptable, resulting in subsotrol injection (SV) PD-1/PD-L1 monoantigen.
today we are taking stock of several insulciply injectable PD-1/PD-L1 immunodrmmune drugs that are currently emerging worldwide.
, PF-06801591 PF-06801591 is an under-skin injection PD-1 monoantigen developed by Pfizer.
last year JAMA Oncology published a controlled study of PF-06801591 subsulvational injections and intravenous injections, which found that subsethic injections did not affect the therapeutic effect of PF-06801591 and did not cause severe skin toxicity.
this is a Phase I, open label, multi-center, dose incremental study.
between March 8, 2016 and March 5, 2018, 40 patients over the age of 18 with localized advanced or metastasis solid tumors from four U.S. medical centers were included in the study.
0.5, 1, 3 or 10 mg/kg PF-06801591 every 3 weeks, or 300 mg every 4 weeks.
started increasing the dose after 2 to 4 patients registered for use at each dose level, and more patients were added to each queue for further evaluation.
in this Phase I dose incremental trial, 25 patients received intravenous dose incremental PF-06801591 (0.5, 1, 3 or 10 mg/kg), while 15 patients received subsuplitic injections in increasing doses.
dose-related toxicity was not observed.
4 cases (16%) in the intravenous group and 1 case (6.7%) in the subsuperial injection group had adverse treatment-related events of level 3 or above.
-related adverse events occurred in 10 patients in the intravenous treatment group and 3 patients in the subsocisal treatment group.
no corresponding dose-related adverse events were observed during intravenous dose increase, and no severe skin toxicity effects occurred during subsuplisive injections.
5 patients received PF-06801591 intravenous injections, and 2 patients received intraskin injections, with an overall objective effective rate of 18.4%.
total survival of subsuplibal injection group was 10.7 months, and the median total survival of intravenous drug group was not measured.
results showed that PF-06801591 had shown anti-tumor activity in a variety of tumor types compared to 1 intravenous injection every 3 weeks, and had good tolerance and no serious skin toxicity was found.
subsexual injections at PF-06801591 can improve patient compliance and are expected to be an alternative to intravenous injections.
II, KN035 KN-035 is a fusion protein composed of recombinant anti-PD-L1 humanized mono-domain antibodies and Fc regions, which, compared with other similar drugs, is due to the small molecular weight and high activity of KN-035. The characteristics of strong penetration, good stability, low immunogenicity and low toxicity of tumor tissue show excellent tumor suppression effect in the preclinical stage of the study, while KN-035 is more convenient in clinical use by using the method of injection under the skin.
KN-035 was originally developed by Suzhou Corning Jerry Biotech (Alphamab) and later developed by Suzhou Corning Jerry Biotech and Sichuan Thought Di Pharmaceuticals (3D Medicines).
at the 2020 ASCO Annual Meeting, the company released clinical trial data for KN035 single-drug late-stage solid tumors in high microsatellite instability (MSI-H) tumors/mismatch repair functional defects (dMMR).
this study is a key clinical trial to explore the treatment of MSI-H/dMMR advanced solid tumors in KN035, using a one-arm open label design, and the main endpoint of the study is the confirmation objective mitigation rate (ORR) evaluated by the Independent Review Committee.
the MSI-H status of colorectal cancer (CRC) and stomach cancer (GC) was confirmed by the Central Laboratory, and the MSI-H/dMMR status of other tumors was assessed by local laboratories.
: The results of the trial are released until 17 December 2019.
103 cases of MSI-H/dMMR advanced cancer in 25 centers in China.
major therapeutic populations (PEPi) included 39 advanced CRC cases that had previously received at least fluorouracil, oxalipari and olithycomtretherapy treatments and 11 advanced GCs that had previously received at least first-line standard treatment, with a medium follow-up time of 7.5 months.
The overall population included 65 CRC cases (24 previously treated with fluorouracil and oxaliplatin or elitricon), 18 gastric cancers and 20 other tumors, with a medium follow-up time of 6.7 months.
highlights include: the confirmed objective mitigation rate in the PEPi population was 30% (95% CI: 17.9%, 44.6%), and the 80% mitigation rate continued at the data cut-off time.
CRC patients who had previously been treated with fluorouracil and oxaliplatin or olithycon were 54.2% (95% CI: 32.8%, 74.4%).
confirmed objective mitigation rate for the overall population was 34.0 per cent (95 per cent CI: 24.9 per cent, 44.0 per cent) and 85.7 per cent was sustained at the data cut-off date.
6.6 months for both PEPi and the population as a whole.
overall survival of the two groups was not achieved.
14 patients (13.6%) had treatment-related adverse events (TRAEs) at levels 3-4.
there were no reports of level 5 TRAE, pneumonia or colitis.
9 patients had local injection site reactions, all level 1 or 2.
results showed that KN035 showed long-lasting anti-tumor activity and controlled safety in patients with advanced MSI-H/dMMR cancer.
, IMMH-010 On April 13, Red Day Pharmaceuticals registered on ClinicalTrials.gov to launch its Phase I clinical trial of the PD-L1 drug Amtefen (IMMH-010) for the treatment of advanced malignant solid tumors.
The study, led by Professor Wu Yilong of Guangdong Provincial People's Hospital, planned to include 96 patients with malignant solid tumors to assess the safety and tolerance of amphifen 60, 120, 240, 360 mg in the treatment of malignant solid tumors, determine the maximum toy dose of amphifen and the recommended dose of Phase II, and assess the pharmacological effects of food on patients with advanced solid tumors.
the appearance of under-the-skin injection method will greatly improve the convenience and safety of patients' drug treatment, improve patient compliance, improve patients' quality of life, and even form outpatient tumor treatment routine.
under the current trend of immuno-led tumor treatment, the optimization of drug use may bring about a change in tumor treatment and an important hope for long-term tumor management in the future.
: 1.Johnson ML, Braiteh F, Grilley-Olson JE, et al. Assessment of Subcutaneous vs Intravenous Administration of Anti-PD-1 Antibody PF-06801591 in Patients With Advanced Solid Tumors: A Phase 1 Dose-Escalation Trial. JAMA Oncol 2019. 2.Envafolimab (KN035) in advanced tumors with mismatch-repairdy. J Clin Oncol 38: 2020 (suppl; abstr 3021). 3. Study of IMMH-010 in Patients With Advanced Malignant Solid Tumors.