Joyo starts its first pivotal trial

Asian drug development is thriving, with multiple groups in the region preparing to start pivotal studies, according to new listings on clinicaltrials.gov. One is Joyo Pharmatec, which now appears focused on its ROS1 inhibitor JYP0322, after selling ex-China rights to two preclinical RAS programmes to Erasca last year. JYP0322, designed to overcome ROS1 resistance mutations such as G2032R, will be tested in second-line ROS fusion-positive NSCLC.

InxMed is also targeting NSCLC with its Boehringer-originated FAK inhibitor ifebemtinib, while Takara hopes that its study will support Japanese approval for its anti-NY-ESO-1 engineered T-cell receptor mipetresgene autoleucel in synovial sarcoma. Finally, L&L Biopharma is keeping the faith with Tim-3, with LB1410, a bispecific antibody that also hits PD-1. 

First pivotal efforts

All four newly disclosed pivotal studies signal the first entries into phase 3 development for these assets. Joyo’s study, which will take place in China and is slated to start in September, will evaluate JYP0322 against chemotherapy in NSCLC patients who have previously received one or two ROS1 tyrosine kinase inhibitors.

Supporting this move, the company presented phase 1 data at AACR in April, where JYP0322 demonstrated an ORR of 55% in 22 NSCLC patients who had received prior ROS1 inhibition.

In the broader ROS1 landscape Nuvation, which gained FDA approval for Ibtrozi in NSCLC irrespective of therapy line, has recently moved into earlier lines of treatment, while Nuvalent has begun a US filing for its contender, zidesamtinib, in the second line; however, first-line plans are still unclear.

Another Chinese group, InxMed is also preparing a phase 3 in NSCLC, but in the front line. This trial, to begin this month, will test its FAK inhibitor ifebemtinib, acquired from Boehringer in 2017, plus InventisBio’s KRAS G12C inhibitor garsorasib, versus BeOne’s PD-1 inhibitor Tevimbra plus chemo.

This could become the second indication for ifebemtinib in China, as InxMed also plans to submit a BLA this year for ovarian cancer, though this will be backed by phase 2 data alone.

NY-ESO-1

Meanwhile, Takara Bio has had to shift its filing strategy in Japan for the anti-NY-ESO-1 engineered T-cell receptor mipetresgene autoleucel in synovial sarcoma. It initially planned to file this in 2023 based on results from a phase 1/2 trial, using the conditional pathway, but the Japanese regulator told it to conduct a phase 3 trial.

However, the study, to start in November, is uncontrolled, merely testing mipetresgene autoleucel following cyclophosphamide/fludarabine pretreatment, with a target enrolment of just five patients.

Previously the leading competitor in this space, Adaptimmune, had also planned to seek approval for an anti-NY-ESO-1 T-cell receptor programme, letetresgene autoleucel, after reporting positive data at the Connective Tissue Oncology Society meeting last year. However, the company recently sold the rights to US WorldMeds.

Tim-3

And L&L Biopharma is moving forward where others have stepped back. The Chinese company is starting its first pivotal trial with LB1410, a PD-1 x Tim-3 bispecific antibody, in combination with the company’s LB4330, a Claudin18.2 x CD8 fusion protein, in relapsed cervical cancer. 

At ASCO 2025 the company reported two partial responses in this patient population, although this was with LB1410 monotherapy. No data from the combination of LB1410 and LB4330 in cervical cancer have been released yet.

Tim-3 has proven a difficult target for the industry. Last July GSK reported in its first-half earnings release that its antibody cobolimab had failed, while AstraZeneca and Bristol Myers Squibb previously exited the space.

Recently listed Asian pivotal studies

Source: OncologyPipeline & clinicaltrials.gov.