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The month ahead: May’s remaining events

ASCO is fast approaching, but in the meantime Olema will have an important readout.

May has already seen big binary data readouts from Glycomimetics and MacroGenics, and another large radiopharmaceuticals purchase by Novartis. The rest of the month promises to be just as active, with conference activity ramping up – and the month ending with the big one, the annual ASCO meeting in Chicago.

Meanwhile, Jiangsu HengRui and Elevar could finally get US approval of their PD-1 latecomer camrelizumab, while Bristol Myers Squibb will be hoping for two new uses for its Car-T therapy Breyanzi that, along with another recent nod, could help double the number of eligible patients.

ASCO expectation

Arguably the biggest oncology event of the year, the ASCO meeting, will begin on 31 May; presentations to look out for include a historic double plenary from AstraZeneca, featuring the Adriatic study of Imfinzi in SCLC, and the Laura trial of Tagrisso in stage III NSCLC maintenance.

The full ASCO abstract texts will become available on 23 May, except for late-breakers, which will go live on the morning of their presentations.

Before that, two smaller oncology conferences will take place imminently in Europe: the Association for Cancer Immunotherapy (CIMT) annual meeting, and the ESMO Breast Cancer congress.

One company that has promised data at the latter is Olema, which will present updated phase 1/2 results with a combination of its SERD palazestrant and Novartis’s CDK4/6 inhibitor Kisqali in oestrogen receptor-positive, HER2-negative disease.

The group will hope for an improvement over the one partial response seen so far among 19 patients, as reported at last year’s San Antonio Breast Cancer Symposium. Olema had also tested palazestrant alongside Pfizer’s Ibrance, but has plumped for Kisqali for its first-line phase 3 combo trial, currently in the works.

Faron also expects data next week with bexmarilimab, its lead project and the only anti-Clever-1 MAb in development, according to OncologyPipeline. The results will come from the phase 2 portion of the Bexmab trial, testing the project in myelodyspastic syndromes patients failed on hypomethylating agents. The phase 1 part of the study, presented at last year’s ASH, showed a 100% response rate among 10 MDS patients, which included five previously treated with hypomethylating agents.

German Merck’s interim

There could also be an update in May on xevinapant, Merck KGaA’s current big cancer pipeline bet and the industry’s most advanced oral IAP (inhibitor of apoptosis proteins) inhibitor. Merck licensed xevinapant from Debiopharm in March 2021 for €188m up front.

The phase 3 Trilyx study in squamous head and neck cancer is due an interim analysis in the second quarter – this was originally expected last year, and then last quarter. Merck has played down the prospect of the study being halted for efficacy, and Jefferies analysts see the most likely scenario as continuation to full analysis, due in around a year. However, there is also the possibility of having to stop the trial for futility, which would deal a big blow to Merck’s cancer ambitions.


May’s upcoming events

Interim analysis of Trilynx studyImminent?Ph3 trial tests Merck KgaA’s xevinapant in squamous head and neck cancer; had previously been expected in Q1
Bank of America Merrill Lynch Global Healthcare Conference14-16 MayLas Vegas
CIMT (Cancer Immunotherapy) annual meeting15-17 MayMainz, Germany
ESMO Breast Cancer annual congress15-17 MayBerlin, Germany
Ph1/2 data with Olema’s palazestrant + Novartis's Kisqali15 MayTrial in ER+ve, HER2-ve, advanced and/or metastatic breast cancer; previously 1 response among 19 pts
Camrelizumab PDUFA16 May1st-line liver cancer (rivoceranib combo), based on Cares-310 trial
HC Wainwright Annual BioConnect investor conference20 MayNew York
Readout from ph2 part of Bexmab trialw/c 20 MayTrial tests Faron’s Clever-1 inhibitor bexmarilimab in r/r MDS
AstraZeneca investor day21 MayIn person & virtual
Breyanzi PDUFA23 Mayr/r FL (additional use), based on Transcend FL
CHMP day30 MayDecisions could come on Regeneron’s odronextamab (FDA CRL Mar 2024); AstraZeneca’s Tagrisso in 1L EGFRm NSCLC (Flaura2, FDA approved Feb 2024)
Breyanzi PDUFA31 Mayr/r MCL (additional use), based on Transcend NHL 001
ASCO 202431 May - 4 JuneSee ApexOnco's ASCO preview 

Source: OncologyPipeline.