The news widespread in the industry that Hengrui has received the pharmaceutical product registration approval for its anti-PD-1 camrelizumab has been confirmed recently. It took 24 days from the beginning of review to the receipt of approval on May 29.
Camrelizumab (R&D code: SHR-1210, trade name: Ailituo) is approved as a third-line therapy for the relapsed/refractory classical Hodgkin lymphoma (R/R cHL) this time, which is the second Chinese-produced anti-PD-1 monoclonal antibody drug approved for this indication following Innovent’s Tyvyt (sintilimab, approved for marketing by the National Medical Products Administration on Dec. 27, 2018, used to treat R/R cHL patients who have received at least second-line systematic chemotherapies) and the fifth anti-PD-1 monoclonal antibody drug approved for marketing in the Chinese market. With this, there is a new choice in the therapeutic area of R/R cHL.
Let’s first learn about what R/R cHL is.
Hodgkin’s lymphoma (HL) is a kind of malignant tumor originating in the lymphohematopoietic system, which mainly occurs in children and youth, with the morbidity accounting for 15%~25% of all lymphomas and generally with a good prognosis. More than 80% classical Hodgkin lymphomas (cHL) can be cured after first-line therapies, and even for patients with R/R cHL, about 50% of them can be cured with high-dose chemotherapies in combination with autologous stem cell transplantation (ASCT).
However, it’s difficult for R/R cHL patients who relapse after receiving ASCT or are not suitable for ASCT or hematopoietic stem cell transplantation (HSCT) to reach complete remission or long-term survival due to the limited treatment choices. The 9p24.1 cytogenetic abnormalities of cHL cells result in overexpression of PD-1 ligands: PD-L1 and PD-L2, which provides the theoretical basis for the PD-1/PD-L1 inhibitor treatment.
As a humanized anti-PD-1 IgG4 monoclonal antibody, camrelizumab has a high affinity with human PD-1 and has demonstrated good anti-tumor efficacy in the preclinical study.
Hengrui Medicine released clinical data of efficacy of camrelizumab in treating R/R cHL at the 21st annual meeting of the CSCO (Chinese Society of Clinical Oncology) last year.
The study recruited 75 R/R cHL patients aged above 18, and all the patients were R/R cHL patients who relapsed after receiving ASCT or who received ≥2-line systemic chemotherapies and were not suitable to receive stem cell transplantation. They received camrelizumab 200mg q2w until there was a disease progression or intolerable toxicity.
The results by Mar. 18, 2018 (6 months after the last subject was enrolled) showed that camrelizumab demonstrated positive effectiveness and safety in treating R/R cHL, wherein, the objective response rate (ORR) reached 84.8% and complete response (CR) reached 30.3%. The significant reduction of the target lesion tumor load of patients could be observed during the study.
In terms of safety, camrelizumab monotherapy showed good safety in treating R/R cHL patients, with tolerable adverse reactions. Except the reactive skin capillary hyperplasia, other common adverse events were comparable to similar products, and the reactive skin capillary hyperplasia had mild symptoms and automatically regressed about half a year later.
Let’s see the efficacy of other anti-PD-1 monoclonal antibodies in R/R cHL. And if you want to know more about pharma industry, Pharmasource, a professional platform where thousands of health care products suppliers gathered, could help you.
Nivolumab
Nivolumab is a humanized anti-PD-1 monoclonal antibody and the first immune checkpoint inhibitor approved by the FDA to treat R/R cHL, of which the effectiveness was first proved in the Phase I clinical trial CheckMate 039. Among the 23 R/R cHL patients, 78% failed the antibody-drug conjugate BV (Brentuximab ...
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