The month ahead: July’s upcoming events

July will see a lull in the biopharma conference schedule, but there are still plenty of events coming up this month. Approval decisions are due on the likes of BeiGene’s PD-1 inhibitor Tevimbra and Novartis’s Kisqali for new and earlier uses, while ALX and Fibrogen are both facing key data readouts.

Meanwhile, Johnson & Johnson will kick off the latest earnings season, with its second-quarter results due on 17 July.

Aspen rocky?

In July ALX is set to unveil full results from the Aspen-06 trial of its CD47 inhibitor evorpacept in late-line HER2-positive gastric cancer, with data expected on duration of response and survival. The study tests evorpacept plus Herceptin, Cyramza and paclitaxel, versus Herceptin, Cyramza and paclitaxel alone.

The company previously reported an ORR win from a subset of patients in the study; however, ALX’s stock has sunk back to levels seen before that readout, likely not helped by an underwhelming result from another trial, Aspen-07, and scepticism about CD47 in general after various setbacks here.

The field of cytokines has also had more downs than ups, but one company that still has faith is Imunon (formerly known as Celsion). The group’s DNA-based therapy IMNN-001 is designed to stimulate production of IL-12 at the tumour site.

In July the company is set to report topline data from its phase 2 Ovation-2 trial testing IMNN-001 in combination with neoadjuvant chemotherapy, versus chemo alone, in ovarian and other gynaecologic cancers. The trial's primary endpoint is PFS.

Interim results reported last September found that the addition of IMNN-001 prolonged PFS by around three months. However, Imunon has cautioned that the study isn’t powered for statistical significance, and is designed only to inform phase 3 plans.

July might also see long-awaited data from the phase 3 Lapis study, testing Fibrogen’s anti-CTGF antibody pamrevlumab as neoadjuvant therapy in pancreatic cancer. The results had originally been expected by March, but have been delayed twice and are now due in the third quarter.

The primary endpoint of the study, which pits pamrevlumab plus chemo against chemo alone, is overall survival. Fibrogen has blamed the long wait on a slowdown in events, adding that this is a normal phenomenon as a trial’s patient pool dwindles. However, delays of this kind aren’t usually good omens. Pamrevlumab has already failed in idiopathic pulmonary fibrosis and Duchenne muscular dystrophy.

Approvals approaching?

As for potential approvals in July, the Natalee trial could broaden Kisqali’s current indication of metastatic breast cancer into adjuvant use, potentially adding multi-million dollar sales to a product that already brought in $2bn last year. 

The CDK4/6 inhibitor’s PDUFA date in the adjuvant setting is unclear, but Novartis has disclosed that it filed for approval here in the fourth quarter of 2023, and used a priority review voucher.

BeiGene’s Tevimbra, meanwhile, got the FDA go-ahead in March for second-line oesophageal squamous cell carcinoma, and July could see it get the nod for first-line use. The drug is also awaiting a decision in gastric or gastroesophageal junction adenocarcinoma, due by December.

Meanwhile, AstraZeneca’s PD-L1 blocker Imfinzi could add neoadjuvant NSCLC to its list of indications, while J&J and Genmab’s Darzalex looks set to be included in another first-line multiple myeloma combo, on top of its already impressive roster.

July’s upcoming events

Source: OncologyPipeline.