Camrelizumab: First Global Approval

Markham, Anthony; Keam, Susan J.

doi:10.1007/s40265-019-01167-0

Cited by 180 publications

(134 citation statements)

References 15 publications

Supporting

Mentioning

133

Contrasting

Order By: Relevance

“…10,[32][33][34][35][36][37][38] This larger experience of camrelizumab in Chinese patients has been the basis of its approval in China for the treatment of patients with Hodgkin's Disease. 10,34,39 Since all studies were conducted in Chinese population so far, our study provided clinical evidence in Australian and expanded the generalizability of camrelizumab in solid tumors in patients outside of China.…”

Section: Discussionmentioning

confidence: 82%

A First-in-Human Dose Finding Study of Camrelizumab in Patients with Advanced or Metastatic Cancer in Australia

Lickliter¹,

Gan²,

Voskoboynik³

et al. 2020

DDDT

View full text Add to dashboard Cite

Purpose: Camrelizumab inhibits PD-1 in non-clinical models and showed typical non-clinical pharmacokinetic (PK) and safety profiles for an IgG4 monoclonal antibody. We report results from the First-inHuman Phase 1 trial of camrelizumab in Australian population. Methods: Camrelizumab was administered to patients with advanced solid tumors who had failed standard therapies. In the dose-escalation phase (n=23), camrelizumab was administered intravenously at 1 mg/kg, 3 mg/kg, 6 mg/kg, and 10 mg/kg every 2 weeks. In dose expansion (n=26), camrelizumab was given at 200 mg or 600 mg every 4 weeks. Results: Two dose-limiting toxicities were observed during dose escalation: transaminase elevation and diarrhea (both grade 3). Overall, treatment-related adverse events were consistent with the expected toxicity profile of immune checkpoint inhibition, with the striking exception of the dose-related development of angiomatous skin lesions characterized as reactive cutaneous capillary endothelial proliferation. The PK profile showed a doseprogressive increase in half-life from 3 days at 1 mg/kg to 7 days at 10 mg/kg. Moreover, receptor occupancy assays showed a PD-1 occupancy of >50% in most patients out to 28 days post-dose. The objective response rate was 15.2% (95% CI 6.3-28.9). Conclusion: Camrelizumab has manageable toxicity and encouraging preliminary antitumor activity in advanced solid tumors in Australia. Clinical Trial Registration: ClinicalTrials.gov Identifier: NCT02492789.

show abstract

Section: Discussionmentioning

confidence: 82%

A First-in-Human Dose Finding Study of Camrelizumab in Patients with Advanced or Metastatic Cancer in Australia

Lickliter¹,

Gan²,

Voskoboynik³

et al. 2020

DDDT

View full text Add to dashboard Cite

show abstract

“…11 Since then, many patients with advanced STS in China started to use PD-1 inhibitors offlabel, particularly due to the introduction of local and cheaper PD-1 inhibitors into the market. 21,22 However, as shown in the phase 2 trial of pembrolizumab in STS, PD-1 inhibitor monotherapy has limited efficacy in most patients with advanced STS.…”

Section: Discussionmentioning

confidence: 99%

Safety and Efficacy of PD-1 Inhibitors Plus Chemotherapy in Advanced Soft Tissue Sarcomas: A Retrospective Study

Tian

Yang

et al. 2020

CMAR

View full text Add to dashboard Cite

Purpose: Programmed cell death 1 (PD-1) inhibitors are ineffective as monotherapy for the treatment of soft tissue sarcomas (STS). However, increasing evidence shows that the combination of PD-1 inhibitors and chemotherapy is efficacious and safe for many types of malignancies, including STS. This study aimed to assess the safety and efficacy of doxorubicin chemotherapy plus PD-1 inhibitor in the treatment of metastatic STS. Patients and Methods: We retrospectively reviewed 21 patients with metastatic STS who received doxorubicin chemotherapy plus a PD-1 inhibitor between November 2017 and October 2018. Results: The objective response rate was 47.6%, the disease control rate was 71.40%, and the median progression-free survival was 6 months (95% CI, 2-8 months). The average change in target lesion diameter from baseline was −25.15 ± 41.61. Majority of the patients experienced grade 1/2 adverse events (AEs), the grade 3/4 AEs were few. The most common grade 3/4 AEs were as follows: leukopenia (23.8%) and anemia (19.0%). Immune-related AEs were common and included hypothyroidism (14.3%) and pneumonitiss (9.5%). No drug related deaths occurred. Conclusion: This study provides preliminary evidence that the combination of doxorubicin chemotherapy and PD-1 inhibitor for advanced STS is safe and effective. We plan to conduct randomized clinical trials to confirm and characterize the activity of the chemotherapyimmunotherapy combinations in the treatment of sarcomas.

show abstract

“…Both drugs have been approved for the treatment of relapsed or refractory classical Hodgkin's lymphoma. [17][18][19] In the CheckMate153 study (NCT02066636), patients with advanced NSCLC who responded effectively to nivolumab treatment were divided into a continuous medication group and interruption group. The results showed that the rates of PFS and OS in the continuous medication group were significantly higher than those in the interruption group.…”

Section: Discussionmentioning

confidence: 99%

Duration of immunotherapy in patients with advanced lung adenocarcinoma with negative driver genes: case report and literature review

et al. 2020

View full text Add to dashboard Cite

Here, we report two cases of advanced non-small cell lung cancer (NSCLC) in patients with negative driver genes who received ICI treatment for less than two years but continued to benefit from their administration after drug withdrawal. The first patient was diagnosed with left lung adenocarcinoma, cT1cN3M1c, stage IVb, and after four cycles achieved a completed response (CR). After 10 cycles of camrelizumab treatment, immunotherapy was discontinued because of hepatotoxicity. When the drug was discontinued, the curative effect was evaluated as CR. At the last follow-up, the drug withdrawal time had been more than 20 months, and the response was maintained at CR, with PFS of over 30 months. In the second case, the patient was diagnosed with left lung adenocarcinoma, cT1N3M1c, stage IVb. The patient was treated with sintilimab, and due to cardiac and skin toxicity, the patient withdrew from the trial after five cycles of immunotherapy. After drug withdrawal, the curative effect of the patients was maintained at PR. At the last follow-up, the drug withdrawal time was more than three months, and the curative effect was evaluated as PR. The PFS was more than nine months. In conclusion, whether the drug can be discontinued in advance after immune checkpoint inhibitor (ICI) therapy has been effective remains a concern, and at present there is no final conclusion in the medical profession. However, the results of this study indicate that early withdrawal of immunotherapy due to adverse reactions might also benefit patients with advanced lung adenocarcinoma with negative driver genes who achieve an early response to immunotherapy.

show abstract

Camrelizumab: First Global Approval

Cited by 180 publications

References 15 publications

<p>A First-in-Human Dose Finding Study of Camrelizumab in Patients with Advanced or Metastatic Cancer in Australia</p>

<p>A First-in-Human Dose Finding Study of Camrelizumab in Patients with Advanced or Metastatic Cancer in Australia</p>

<p>Safety and Efficacy of PD-1 Inhibitors Plus Chemotherapy in Advanced Soft Tissue Sarcomas: A Retrospective Study</p>

Duration of immunotherapy in patients with advanced lung adenocarcinoma with negative driver genes: case report and literature review

Contact Info

Product

Resources

About