DelveInsight’s consultants have put their views and thoughts on the much-awaited Plenary Session Update from the Day 3 of ASCO21 in Nasopharyngeal Carcinoma. Continue to know more.
Abstract #LBA2: Junshi Biosciences’ encouraging results from Phase III JUPITER-02 trial to treat recurrent or metastatic nasopharyngeal carcinoma R/M NPC
Nasopharyngeal Carcinoma (NPC) is endemic to Southeast Asia and Southern China, having a much higher incidence in China, as compared to worldwide incidence. The first-line therapy for R/M NPC is GP (Gemcitabine and Cisplatin) chemotherapy, which is the current standard of care for this aggressive form of NPC. However, the mPFS of this standard of care is only about 7 months which highlights the need for a new and better alternative standard of care for R/M NPC. We believe that Toripalimab could be this much-needed alternative, as revealed in the interim analysis of the phase III JUPITER-02 trial during the plenary session of the ASCO 2021 virtual meeting.
The global phase III JUPITER-02 trial was conducted in Mainland China, Taiwan and Singapore and had screened 408 patients, out of which 289 patients were randomized for the trial. Excitingly, the trial met both primary and secondary endpoints. An mPFS of 11.7 months was achieved in the toripalimab plus chemotherapy arm as compared to 8 months in the placebo plus chemotherapy arm, which as per the investigators, was statistically significant and clinically meaningful. The presenter also mentioned that an improvement in PFS was observed across all key subgroups and both PD-L1 positive and inactive patients benefited from the combination of toripalimab and chemotherapy. The mOS was NE for both arms, but a decline of 40% was observed in the toripalimab arm as compared to the placebo arm. The 2-year OSR was superior in the toripalimab arm vs. the placebo arm with 77.8% and 63.3%, respectively. A significant difference in the ORR was observed with 77.4% in the toripalimab arm and 66.4% in the placebo arm. A statistical significance of DoR was also observed with DoR of 10.8 months and 5.7 months in the toripalimab arm and the placebo arm, respectively.
Furthermore, the instance for immune-related AEs was higher in the toripalimab arm and was expected for immunotherapy. The oral presentation was summarized by mentioning that a second interim OS analysis will be performed at the pre-specified final PFS analysis followed by a final OS analysis. Also, no novel safety signals were identified for the combination of toripalimab and GP. Thereby, we can conclude that the combination of toripalimab and GP could be a possible new standard of care for the first-line treatment of R/M NPC.
Related Clinical Updates on Junshi’s anti-PD-1?
Toripalimab, the first anti-PD-1 monoclonal antibody approved for marketing in China as Tuoyi, has multiple ongoing or completed pivotal clinical trials for a variety of tumors like lung, esophagus, bladder, liver, kidney, skin and others. The drug was granted conditional approval from the NMPA for the third-line treatment of patients with R/M NPC in February 2021. Toripalimab was granted another conditional approval by the NMPA for the treatment of patients with locally
advanced or metastatic urothelial carcinoma who failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy in April this year. Moreover, a rolling BLA of toripalimab for the treatment of R/M NPC is underway in the US, whereas Coherus and Junshi Biosciences are also planning to file for additional BLAs for the drug in various rare as well as extremely prevalent cancers.
Moreover, it can be said that anti-PD-1 is emerging as a new treatment option for R/M NPC, as apart from Coherus and Junshi Biosciences, other key players are also conducting phase III trials of their drug candidates as a treatment for R/M NPC. Jiangsu HengRui Medicine is evaluating its anti-PD-1, camrelizumab, in combination with GP as first-line treatment for R/M NPC, while Merck is testing pembrolizumab as monotherapy in the subsequent of the line treatment for R/M NPC. NRG Oncology is also conducting a phase III trial of nivolumab with chemotherapy for the first-line treatment for R/M NPC.
Insights- Anti-PD-1 antibody is emerging as a first-line treatment option R/M NPC with both new and established drug candidates in the late phase of clinical development for this indication. This highlights an increasing competition in the dormant NPC market which might lead to a boost in this market in the near future. The increasing focus on developing therapies for this rare indication will help in overcoming an unmet need for effective treatment options and also in providing a better chance of survival for the patients which the existing therapy is unable to deliver.
Key acronyms used: PFS-Progression-free survival; BIRC- Blinded independent review committee; OSR-Overall survival rate; ORR - Objective response rate; DoR - Duration of response; NMPA- National Medical Products Administration.
With the potential of Anti-PD-1 antibody displayed on the table, the competition in Nasopharyngeal Carcinoma is surely going to pique. Let us discuss more about transforming NPC market dynamics. Give us a holler at firstname.lastname@example.org