ASCO

Iovance’s Amtagvi won FDA accelerated approval in February, and Adaptimmune’s afami-cel may not be far behind, but cell therapies for solid tumors come with some extra challenges.

The discussant at ASCO’s NSCLC session said the field would need to “manage expectations” as the drugs do not appear to beat chemotherapy in all-comers. 

Scrip reporter Alaric DeArment is joined by the Datamonitor Healthcare oncology analysts to review key highlights from the recent American Society of Clinical Oncology annual meeting.   

US-based Citeline writer Sarah Karlin-Smith joins Brian Yang and Dexter Yan in China to discuss the US BIOSECURE Act and the recent BIO meeting in San Diego, while Dexter Yan discusses China-related ASCO highlights, in this mixed Chinese- and English-language episode.

In a late-breaker oral presentation at ASCO on the SCORES study with suvemcitug, Simcere revealed a trend favoring an overall survival advantage in platinum-resistant oral cancer, despite immature data.

Positive new and updated data at ASCO for Rybrevant plus lazertinib could position the combo more strongly against Tagrisso in the first-line treatment of high-risk, EGFR-mutated non-small lung cancer. 

Scrip talked to Regeneron at ASCO about REGN7075 and Regeneron’s bispecific development strategy in solid tumors.

Solid tumor CAR-T may succeed AZD7003 where many others have failed as the firm builds its cell therapy pipeline.

Backed by strong progression-free survival results from the China-only, head-to-head HARMONi-2 trial, Akeso/Summit’s ivonescimab could be set to become a global contender against established standard of care Keytruda in first-line, PD-L1-high non-small cell lung cancer.

As the American Society of Clinical Oncology annual meeting drew to a close, Scrip spoke with industry execs about staying competitive, adjusting to policy changes and how artificial intelligence is advancing cancer R&D.

Scrip sat down with Astellas chief medical officer Tadaaki Taniguchi to talk about the drug maker’s plans for taking its Claudin18.2-targeting drug to the US market.

Follow-up data from Merck & Co./Moderna’s KEYNOTE-942 showed durable responses to V940/Keytruda, while Merck said the therapy plays a leading role in its immuno-oncology strategy.

Excluding PD-1 inhibitors in its combination strategy for oncology, preliminary results from GenFleet’s Phase II KROCUS study presented at ASCO demonstrate promising efficacy for fulzerasib plus cetuximab in the first-line treatment of KRAS G12C-mutated, advanced non-small cell lung cancer.

The companies presented data from CARTITUDE-4 in functional high-risk disease, which has a poorer prognosis, while they are also piloting a program to expand Carvykti’s geographic reach.

“Transformative” data could move Daiichi Sankyo and AstraZeneca’s conjugate into ultralow HER2 expressers, and allow its use ahead of chemo in breast cancer.    

The trial offers proof of concept for using Opdivo plus Yervoy as neoadjuvant treatment in melanoma; BMS notes a registrational trial is needed, but it is not clear which IO drugs will advance. 

The antibody-drug conjugate, withdrawn from market for late-line use, is poised to make a return with strong results in DREAMM-7 and 8. GSK plans to refile later this year. 

The results for Imfinzi mark the first significant advance in LS-SCLC in four decades, but will the combination with Imjudo succeed after flopping in CASPIAN?

While the study allowed a crossover, and the overall survival benefit did not reach statistical significance, the drug maker sees the PFS benefit from Tagrisso as likely to drive uptake.

The drug maker presented data from the ASC4FIRST study at ASCO, showing better efficacy and tolerability than imatinib and other tyrosine kinase inhibitors in Ph+ CML in the chronic phase.