On Our Radar: Five ASCO Announcements and Updates We’re Watching

With the 2024 ASCO Annual Meeting kicking off this week in the Windy City, here’s what has caught our eye. and are looking forward to learning and hearing more in the coming days. We will closely follow the #ASCO24 conversations on LinkedIn. With over 5,000 abstracts being published, we highlighted just a handful of what’s to come.

1.   Pfizer recently invested $43B to acquire Seagen, mostly on the merits of its antibody-drug conjugate (ADC) platform. While investments of this magnitude usually take years to manifest in profit, perhaps in this case, the investment might start bearing fruit sooner.

Pfizer plans to unveil efficacy data on its phase 1 (NCT04389632) trial testing SGN-B6A in solid cancer. However, said data has already proven to be sufficient for Pfizer to completely skip the Phase 2 clinical setting and jump to the NCT06012435 Phase 3 trial testing SGN-B6A in Non-small cell Lung Cancer (NSCLC) vs Docetaxel.

2.   AstraZeneca has planned two separate plenary sessions in ASCO 2024, one for its LAURA (NCT03521154) Phase 3 trial testing Osimertinib, and one for ADRIATIC (NCT03703297), a Phase 3 trial testing Durvalumab. Both trials target early stages of lung cancer, with the former targeting stage III NSCLC, and the latter focusing on limited stage small-cell lung cancer (LS-SCLC).

Additionally, a late-breaking abstract presentation on the DESTINY-Breast06 (NCT04494425) Phase 3 trial testing Enhertu in HER2-low breast cancer will be presented. Enhertu is the product of AstraZeneca’s partnership with Daiichi Sankyo, and the results of this trial could potentially provide even HER2-ultra low expression patients, previously ineligible, with access to the drug.

3.   In 2022, Merck licensed sacituzumab tirumotecan, a TROP2-targeting ADC from China-based Kelun. Merck plans to present efficacy data from the OptiTROP-Breast01 (NCT05347134) Phase 3 trial in previously treated, triple negative breast cancer (TNBC) at ASCO 2024. 

OptiTROP-Breast01, a China-based trial, met its primary endpoint of PFS in an interim analysis, and Kelun has already filed for regulatory approval in China. The current lack of specific details on the patients’ baseline characteristics makes it difficult to assess how these Chinese population results correlate with a Western population. Still, they certainly paint a positive outlook for Merck’s USA-based (NCT06393374) Phase 3 trial, testing sacituzumab tirumotecan in adjuvant TNBC.

4.   Mabwell Therapeutics, a biotechnology company developing antibody and protein-based drugs, plans to announce the latest data on its phase ½ (NCT05216965) trial testing 9MW2821 in solid cancer. More specifically, said data will focus on urothelial carcinoma (UC), cervical cancer (CC), esophageal cancer (EC) and TNBC. 9MW2821 is a Nectin-4 targeting ADC, that is the first of its kind to have published efficacy data in CC, EC and TNBC. It has received multiple regulatory designations in recent months for esophageal and cervical cancer.

5.   AffyImmune is a biotechnology company developing chimeric antigen receptor (CAR) T-cell therapies, planning to announce in ASCO 2024 safety and early efficacy data of its Phase 1 (NCT04420754) trial, testing AIC100 in Thyroid Cancer. AIC100 is an ICAM-1 targeting and affinity-tuned LFA-1 binder CAR-T therapy. AffyImmune has already revealed that there was a patient with metabolic complete response (mCR) in said trial. This marks the first documented case of a CAR-T therapy achieving complete response in solid cancer after a single intravenous (IV) dose, and showcases the potential it has to bypass the barriers this kind of therapy currently has in this setting.

We have a busy few days ahead listening, learning and working on our post-ASCO analysis.