The month ahead: March's upcoming events

With oral selective ER degraders on the agenda again, investors won't have to wait long for their next catalyst, with data from Pfizer/Arvinas's vepdegestrant in the second-line Veritac-2 study featuring among the key upcoming events in March, after a slight delay.

The month will also see the FDA rule on what could be the first approval of AbbVie's c-Met-targeting ADC telisotuzumab vedotin, and a new use for Darzalex Faspro, the subcutaneous version of Johnson & Johnson/Genmab's blockbuster. An even more important catalyst relates to Genmab's Darzalex follow-on, erzotabart, with J&J due to make a decision on whether to opt in to this key project.

Erzotabart is seen as increasingly important way for Genmab to maintain momentum beyond Darzalex, already established as a juggernaut in multiple myeloma. Both MAbs target CD38, but erzotabart is said to be more potent; however, positive uncontrolled data at ASH 2023 came with a 50% discontinuation rate due to adverse events.

The two companies' deal stipulates possible opt-in by J&J on delivery of phase 1/2 head-to-head data, which took place last year. However, a decision by J&J was delayed from 2024 to the first quarter of this year, putting the spotlight on March.

Clinical data

As for clinical trial results, vepdegestrant is in focus after AstraZeneca's rival SERD camizestrant was said to have succeeded in the first-line switch breast cancer study Serena-6.

Most SERD players have now moved to early settings, and the first front-line readout is expected to come later this year from the Persevera trial of Roche's giredestrant. Vepdegestrant too is shooting at the first line, though the preferred CDK inhibitor pairing was recently changed from Ibrance to atirmociclib.

But first the Veritac-2 catalyst will deliver second-line data, expected in the first quarter after a delay from the second half of 2024. This study enrolled all-comers, but has dual PFS primary endpoints in intent-to-treat and ESR1-mutant populations.

Given the precedent of other SERD studies it would be extraordinary to see a benefit in ESR1 wild-type patients, so the main question will be to what extent ESR1m patients drive any all-comers activity.

Another keenly awaited dataset involves the pivotal Fortitude-101 trial of Amgen's anti-FGFR2b MAb bemarituzumab in gastric cancer, in focus because this molecule was the key reason behind the $1.9bn acquisition of Five Prime Therapeutics.

March’s upcoming events

Source: OncologyPipeline.

Also overdue is a mature PFS analysis of the disastrous Tamarack study of MacroGenics' anti-B7-H3 ADC vobramitamab duocarmazine. Dosing in Tamarack was discontinued in mid-2024 after toxicity was seen, and last year's ESMO saw the tally of deaths climb from five to eight.

Despite such obvious red flags MacroGenics talked up the prospects of a phase 3 trial, and as of today vobra-duo remains in its pipeline. How long it stays there is an open question, given the resignation of Scott Koenig as chief executive, announced last October.

It seems that finding a new leader is proving tough, however, with Koenig's departure date recently being extended from 28 February to an open-ended 14 days' notice. It's possible that MacroGenics has bigger fish to fry than providing updates on a project that many investors have effectively written off.

Those investors will also nervously be eyeing US macroeconomic trends, but at least they do have several investment bank conferences to look forward to in March.

And the scientific agenda marches on with London hosting both the World ADC meeting and the Terrapin Advanced Therapies congress. The latter is said to be among Europe's biggest cell and gene therapy events of 2025.