Aside from Summit Therapeutics’ shocking win over Merck’s Keytruda, here’s what else you need to know from the World Conference on Lung Cancer, which is currently underway in San Diego:
ArriVent BioPharma shared early-stage results from an experimental drug in certain lung cancer patients with a mutation called EGFR PACC that has been relatively understudied.
The company said Monday that its dataset is the first for an EGFR inhibitor being tested in a randomized defined population of non-small cell lung cancer patients with this mutation.
In the Phase 1b FURTHER study, 60 patients were randomized to receive either a 240 mg or 160 mg dose of firmonertinib, an EGFR inhibitor approved in China for advanced lung cancer patients with certain mutations. ArriVent licensed the drug from Shanghai Allist Pharmaceuticals in 2021.
ArriVent believes that firmonertinib’s broad activity can make it effective in indications for which AstraZeneca’s blockbuster Tagrisso has not been approved.
In 22 first-line patients who received the high dose, 14 saw their tumors shrink by at least 30% — good for a confirmed response rate of 63.6%. In 23 first-line patients who received the low dose, eight responded, resulting in a 34.8% response rate. ArriVent said that there is one additional unconfirmed partial response at each dose level.
“Because PACC mutation is such an under-understood disease space and is such an under-investigated mutation, the practice currently is very heterogeneous in Europe, in China and other parts of Asia and in the US. Physicians pick different standard-of-care choices, so the randomization to which control arm is still an active discussion,” Xiuning Le, a thoracic medical oncologist and associate professor at the University of Texas MD Anderson Cancer Center, said during a press conference when asked about further studies of the drug in PACC-mutated lung cancer.
Bing YaoAccording to ArriVent’s presentation, PACC mutations account for roughly 12.5% of EGFR mutations and are similar to exon 20 insertion mutations. ArriVent CEO Bing Yao noted that physicians may prescribe Tagrisso off-label for these patients.
ArriVent also shared data showing the drug could reach brain metastases in a handful of patients. “Most importantly, this molecule has really good brain penetration,” Yao said, noting that 30% of patients have brain metastases when they are first diagnosed and 70% will develop them over the course of the disease.
The company is currently studying the drug in the Phase 3 FURVENT trial for patients with EGFR exon 20 mutations, for which Tagrisso is not approved.
Boehringer Ingelheim also revealed results on Monday from a Phase 1b study of its HER2-specific tyrosine kinase inhibitor that is being developed for HER2-mutated non-small cell lung cancer.
In 75 patients who received a 120 mg dose of zongertinib, the confirmed response rate was 66.7%, and Boehringer Ingelheim also said that preliminary activity of the drug against brain metastases was seen. The therapy was designed to spare wild-type EGFR to reduce toxicities.
“While these mutations are rare, they are critical drivers in a subset of non-small cell lung cancer cases, and current treatment options are severely limited. Patients with this type of cancer typically face a poor prognosis, with approximately 50% responding to first-line treatment and only 20% responding to second-line therapy,” John Heymach, the study’s principal investigator and an oncologist at MD Anderson, said in a statement.
A Phase 3 study called Beamion LUNG-2 is looking at zongertinib as a first-line treatment for advanced lung cancer with activating HER2 mutations. It is currently enrolling.
Plus, news from AstraZeneca and Bayer:
- Bayer on Monday shared data for its experimental drug BAY 2927088 in HER2-mutated lung cancer. The drug had a response rate of 72.1% in 43 patients. However, there was one death in the study that was related to treatment.
- AstraZeneca on Sunday detailed results from NeoCOAST-2. The Phase 2 study included data showing its Daiichi Sankyo-partnered antibody-drug conjugate Dato-DXd could potentially be used in combination with Imfinzi in early-stage lung cancer patients before and after surgery.