Western biopharma investors who still ignore the speed with which drug development is progressing in China do so at their peril. A measure of this was on display at the 22nd annual instalment of the Chinese Society of Clinical Oncology meeting, which took place in Xiamen on September 18-22.
Immuno-oncology was absolutely the hottest topic, Cristian Chen, a healthcare analyst for a long-only fund based in Shanghai who attended the conference, tells Vantage. With five anti-PD-(L)1 drugs now approved locally across six indications, the chase is on to expand their use into other cancers.
Jiangsu Hengrui’s Ailituo, for instance, in May became the second immunotherapy to gain a Chinese label in classical Hodgkin’s lymphoma. Jiangsu now seems to be targeting second-line liver cancer, based on final data presented at CSCO showing survival in line with that seen with Keytruda or Opdivo.
The group is also planning to combine Ailituo with Aitan, a VEGFr2 kinase inhibitor licensed from Advenchen Laboratories, in first-line NSCLC. The combo is already in development for front-line gastric cancer, a setting where Aitan recently failed as monotherapy.
Elsewhere in Hodgkin’s lymphoma, Chinese investors await approval of Beigene’s tislelizumab, and an update of the study backing this was presented at CSCO. And, while Shanghai Junshi’s Tuoyi is already approved for melanoma, its highlight was a second-line bladder cancer trial – a use with no China-approved checkpoint blockers – showing activity clearly driven by PD-L1 positivity.
As for western anti-PD-L1 drugs seeking a foothold in China, Merck & Co’s Keytruda and Roche’s Tecentriq featured. Data with the latter, still not approved or filed in the territory, came in combination with Avastin in first-line liver cancer, a setting in which a western trial will soon feature at the Esmo meeting.
|Selected data from the Chinese Society of Clinical Oncology meeting|
|Approval date||Company||CSCO data||Notes|
|Ailituo (camrelizumab)||Jiangsu Hengrui||Final 2L liver cancer data: 14.7% ORR, 13.8mth OS; Aitan combo study in 1L NSCLC set to begin||Approved in 3L Hodgkin's lymphoma|
|Tislelizumab||Beigene||87% ORR & 63% CR in Hodgkin's; ORR in oesophageal (8%), gastric (17%), liver (17%) & MSI-H/dMMR (19%) tumours||Awaiting approval for Hodgkin's lymphoma|
|Tuoyi (toripalimab)||Shanghai Junshi Bioscience||2L bladder cancer: 26.4% ORR (42.4% in PD-L1+ve subjects), 10.9mth OS||Approved in 2L melanoma|
|Keytruda||Merck & Co||Asian subgroup in KN-181 (2L oesophageal cancer): OS 10.0mth vs 6.5mth for chemo (p<0.0001)||Approved in 1L NSCLC & 2L melanoma|
|Tecentriq||Roche||Avastin combo in 1L liver cancer: 17.1mth OS, 7.3mth PFS||In phIII for various tumours, incl NSCLC & TNBC|
|AK104||Akeso Biopharma||Reasonable safety||Anti-PD-1 x CTLA-4 bispecific|
|KN046||Alphamab||Reasonable safety, but mild anticancer efficacy||Anti-PD-L1 x CTLA-4 bispecific|
|RC48-ADC||Remegen||2L bladder cancer: 13.9mth OS, 6.9mth PFS||Anti-Her2 ADC|
|Ensartinib||Xcovery/Betta||Pretreated Alk+ve NSCLC: 52.6% ORR, 11.2mth PFS||Alk TKI|
|Source: CSCO, via Cristian Chen.|
Other scientific approaches were also on display at CSCO. Very early data on bispecifics against PD-(L)1 and CTLA-4 from the private local groups Akeso Biopharma and Alphamab showed reasonable safety, for instance.
And, at the targeted end of the spectrum, data from Remegen suggested a role for RC48-ACD, an anti-Her2 antibody drug conjugate, in second-line bladder cancer, while Xcovery’s ensartinib, a relatively little-known Alk inhibitor, showed promise in pretreated Alk-positive NSCLC, and against some mutations resistant to other second-generation Alk inhibitors.
With pricing a hot issue, and China showing itself willing to undercut the US massively, the next stage is to see which of these findings translate into a real threat beyond the country’s borders.