The month ahead: October’s upcoming events

With ESMO over, attention now shifts to the next set of conferences, and the so-called Triple meeting is set to be the big October event. Still, World Lung’s Asian edition could steal headlines with the increasing popularity of Chinese drug developers.

In the meantime, FDA approval decisions are due for Bristol Myers Squibb’s anti-PD-1 MAb Opdivo and Amgen’s KRAS G12C inhibitor Lumakras, in perioperative NSCLC and colorectal cancer respectively. And earnings season begins again, with Johnson & Johnson the first to report third-quarter earnings on 15 October.

Perioperative Checkmate

Bristol is seeking approval for Opdivo for neoadjuvant therapy plus chemo, followed by surgery and adjuvant therapy, in stage IIA to IIIB NSCLC. The filing is supported by the Checkmate-77T trial, which showed a similar event-free survival benefit to an analogous study of Keytruda, Keynote-671. Overall survival data from Checkmate-77T aren’t yet available.

Keytruda was approved for perioperative lung cancer around a year ago, but since then an FDA adcom has criticised trials in this setting, in particular the fact that their design makes it tricky to tease out the relative benefits of neoadjuvant and adjuvant therapy.

Still, this didn’t stop AstraZeneca’s Imfinzi getting approved here in the wake of the adcom; Bristol will be hoping for a similarly smooth ride.

Colorectal Codebreak

Amgen, meanwhile, is shooting for a green light for Lumakras in second-line colorectal cancer, a use where Bristol’s Krazati recently pulled ahead. Still, Krazati’s thumbs up was accelerated, and Lumakras has a chance for full approval, based on the Codebreak-300 trial.

The study found a 26% overall response rate with high-dose Lumakras plus Vectibix, versus 0% with investigator’s choice; median progression-free survival was 5.6 months and 2.2 months respectively.

However, Codebreak-300 didn’t show a statistically significant improvement in overall survival, although it wasn’t powered to do so.

And on a cross-trial basis Krazati plus Erbitux looks to have a slight edge, with a 34% ORR in the uncontrolled Krystal-1 study.

Neither drug has so far lived up to expectations, however: Lumakras second-quarter sales totalled $85m, while Krazati brought in $32m.

Conferences

As well as the aforementioned Triple meeting (officially known as EORTC-NCI-AACR) and IASLC Asia Conference on Lung Cancer, other congresses taking place October include the Society for Melanoma Research and the European Association of Nuclear Medicine congresses.

The popular field of radiopharmaceuticals will also feature at an Oppenheimer summit, and various other investment banks also have meetings planned.

Meanwhile Sutro, so far overlooked by big pharma, is promising an update on its next-generation ADCs. As well as its lead asset, the folate receptor alpha-targeting luveltamab tazevibulin, the company is developing a tissue factor-targeting ADC, STRO-004, due to hit the clinic next year. The group recently promised three additional INDs in the next three years, so details on these projects seem likely.

October’s upcoming events

Source: OncologyPipeline.