NPC Highlights: ASCO 2021

As the ASCO event is nearing an end, the pharma and biotech industry is witnessing more and more innovative therapies being evaluated in different types of cancers. Discover what Day 4 brought for the Nasopharyngeal cancer (NPC) domain. 

Abstract # 6000: Jiangsu HengRui’s homegrown anti-PD-1 antibody, Camrelizumab could be another possible standard of care for first-line treatment of R/M NPC

Jiangsu HengRui’s homegrown anti-PD-1 antibody, Camrelizumab has long been tapped as one of the first finishers in China’s heated checkpoint race. The drug has already received approval in China for the treatment of relapsed or refractory classical Hodgkin lymphoma and is now all set to make its mark in the R/M NPC area. 

The current standard of care for R/M NPC in the first-line setting is the platinum-based chemotherapy

of GP, which has a median PFS of 7 months and median OS of 29.1 months. However, camrelizumab, an anti-PD-1 antibody, plus GP had previously shown encouraging anticancer activity in the first-line treatment setting by demonstrating an ORR of 91% and a 12-months PFS rate of 61.4%. The results of a phase III randomized study conducted to investigate Camrelizumab plus GP vs. placebo plus GP for first-line treatment of R/M NPC were presented

during the oral abstract session on the 4th day of the ASCO 2021 virtual meeting.

The study was conducted on Chinese patients, and as of December 31, 2020, 343 patients were screened for the trial, and 263 patients were randomly assigned- 134 patients to the camrelizumab plus GP arm and 129 patients to the placebo and GP arm. The primary endpoint of the trial was IRC-assessed PFS while the secondary endpoints included investigator-assessed PFS, ORR, DCR, DoR, OS and safety. As per the results presented during the oral session, the mPFS per IRC was 10.8 months vs. 6.9 months in the camrelizumab and placebo arm, respectively, thereby indicating that camrelizumab plus GP improved PFS in comparison to placebo plus GP, with a 40% lower risk of disease progression or death. IRC-assessed ORR was 88.1% in the camrelizumab arm vs. 80.6% in the placebo arm. Moreover, camrelizumab plus GP was able to prolong PFS as compared to placebo plus GP, with the risk of disease progression or death being reduced by 51%. The 18-month PFS rate was 34.8% vs. 12.7%, in the camrelizumab and placebo arm, respectively. Even though the

OS was not mature in both the groups, preliminary data revealed an improving trend of survival benefit which was detected in the camrelizumab arm and PFS benefit with the addition of camrelizumab was also observed across all subgroups.

Grade ≥3 TRAEs occurred in 93% of the patients in the camrelizumab arm and 90% of the patients in the placebo arm. The study concluded with the suggestion that first-line treatment of R/M NPC with camrelizumab plus GP could become a standard of care in the future as the addition of camrelizumab to GP was observed to significantly prolong PFS and also had a manageable safety profile.

INSIGHTS- When comparing these results to those of the phase III JUPITER-02 trial that were presented during yesterday’s plenary session, the mPFS and DoR observed for toripalimab plus chemotherapy was slightly better than camrelizumab plus GP in the first-line setting. Since both these trials have been conducted in China, these are two possible competitors for that region. Moreover, Jiangsu HengRui Medicine’s NDA for camrelizumab for treatment of nasopharyngeal carcinoma indication is in priority review stage by NMPA, and toripalimab has already been granted a conditional approval from the NMPA for the third-line treatment of patients with R/M NPC. Other key players are also developing their anti-PD-1 drug candidates like Merck Sharp & Dohme (pembrolizumab; phase III), Akeso Pharmaceuticals (AK104; phase II) and others. The Southeast Asian market also has various companies trying to develop bispecifics for this indication, like Merck Healthcare KGaA’ Bintrafusp Alfa (PD-L1 x TGF-β inhibitor) and Xencor’s Pavunalimab (CTLA-4 x LAG-3 inhibitor), along with others are some key players of the current competitive landscape of nasopharyngeal carcinoma.

R/M NPC- Recurrent or metastatic nasopharyngeal carcinoma; GP- Gemcitabine plus Cisplatin; PFS- Progression-free survival; mPFS: median PFS; IRC- Independent review committee; OS- Overall survival; ORR - Objective response rate; DoR - Duration of response; DCR: Disease control rate; TRAEs: Treatment-related adverse events; AEs- Adverse events; NMPA- National Medical Products Administration.

DelveInsight has covered more abstracts from previous days at ASCO2021 in the Nasopharyngeal Cancer space. Visit to know more.