CHICAGO — This weekend, AstraZeneca cancer R&D chief Susan Galbraith is wearing a lapel pin with the number six, marking the years AstraZeneca has sponsored studies presented at the plenary session of the American Society of Clinical Oncology’s annual meeting.
The company has back-to-back plenaries on Sunday afternoon for its top-selling cancer therapies: Tagrisso and Imfinzi, both of which treat forms of lung cancer. AstraZeneca is hoping to use the data to expand the labels for both drugs — Tagrisso in a form of lung cancer with a specific mutation called EGFR, and Imfinzi in a different, aggressive type of lung cancer.
Johnson & Johnson is aiming to challenge AstraZeneca in EGFR-mutated lung cancer, having shared data on Friday for an injectable version of Rybrevant that would make receiving the drug easier and quicker. Tagrisso is currently the go-to option for treating patients with this type of cancer.
Tagrisso’s continued success
In patients with stage 3 EGFR-mutated non-small cell lung cancer who were not eligible for surgery and had received chemoradiation, Tagrisso cut the risk of cancer progression or death by a whopping 81% in a Phase 3 study.
The LAURA study included 216 patients, all of whom received chemoradiation. Out of those patients, 143 then received Tagrisso. Patients in the control arm received a placebo but were allowed to cross over to get Tagrisso as well.
Tagrisso kept cancer at bay for a median of over three years, while patients who received a placebo had a median progression-free survival of just less than six months. At the interim analysis, overall survival was not significant but trended in favor of Tagrisso, according to the abstract. Overall survival was not adjusted for crossover, lead investigator Suresh Ramalingam said during a press briefing ahead of the plenary presentation.
“This will be practice-changing,” said David Spigel, chief scientific officer at the Sarah Cannon Research Institute in Nashville, during the press briefing.
Tagrisso is already approved for patients with EGFR-mutated lung cancer after surgery or for those who have metastatic disease. AstraZeneca announced in February that Tagrisso improved progression-free survival in the Phase 3 study and that it plans to take the data to regulators across the globe.
An expanded label for patients with unresectable EGFR-mutated non-small cell lung cancer could mean roughly $1 billion more in Tagrisso sales for AstraZeneca, according to Mohit Manrao, the company’s head of US oncology. AstraZeneca expects the FDA to approve the expanded label in the US before the end of this year, he added.
An injectable option
J&J is trying to challenge Tagrisso’s dominance in EGFR-mutated lung cancer with its antibody treatment Rybrevant. On Friday, the company presented new data about an injectable version of Rybrevant combined with lazertinib that showed it’s comparable to the approved version, which is administered via intravenous infusion.
While the IV infusion takes hours and requires patients to visit a medical facility, the injection takes a matter of minutes. Interestingly, an exploratory finding from the study suggests the injectable cut the risk of death by 38% compared to the IV infusion. At the one-year mark, 65% of patients who received injectable Rybrevant plus lazertinib were still alive, compared to 51% who received the IV infusion plus lazertinib.
That might be due to the way the injection works, J&J’s Mark Wildgust, VP of oncology, global medical affairs, told Endpoints News ahead of the presentation. The injected version of the drug is absorbed via the lymphatic system “and presents to the immune system in a very different way than an IV administration,” he said.
“One of the hypotheses that we have is: With subcutaneous Rybrevant, we’re actually potentially tapping in even further into the immune mechanism,” Wildgust said.
The company said it plans to seek approval of the subcutaneous version of the treatment in the US. It already submitted an application for approval in Europe.
Checkpoint for aggressive lung cancer
In patients with limited-stage small cell lung cancer who had received chemoradiation and did not progress, AstraZeneca’s checkpoint inhibitor Imfinzi cut the risk of death by 27% compared to placebo.
Patients who received Imfinzi survived for a median of over four-and-a-half years compared to a median of roughly two years and nine months for those who received placebo.
The Phase 3 ADRIATIC study included 730 small cell lung cancer patients who were divided into three arms — Imfinzi, placebo, and Imfinzi plus Imjudo. The third arm is still blinded and was not reported on Sunday.
Unlike non-small cell lung cancer, small cell lung cancer is a more aggressive disease with an overall five-year survival of around 7%, according to the American Cancer Society.
Pneumonitis, including from radiation, was reported in 38% of patients on Imfinzi and 30% of patients on placebo.