ASCO: Astellas exec jokes that 3 pending drug approvals are turning his hair gray

Astellas is busy. Very busy. With three oncology approvals expected in the next year—two of which are label expansion approvals and one entirely new treatment—it's enough to add a few extra gray hairs. 

“We believe it's going to be a very newsworthy year,” Phil Tennant, Astellas’ senior vice president of U.S. oncology, told Fierce Biotech at the American Society of Clinical Oncology (ASCO) annual meeting.   

“It’s an exceptionally busy year … I didn’t have gray hair 'til this year,” Tennant joked. The industry vet has clocked time working at Big Pharmas Merck & Co., AstraZeneca and Bristol Myers Squibb before Astellas and said he’s never overseen so many planned or pending regulatory approvals in such a short period of time.

Tennant, who was drawn to the Japanese drugmaker’s oncology portfolio when he joined four years ago, said he now has “the privilege of being able to bring those medicines to patients as they come through.”

The leader’s sentiments align well with ASCO’s theme this year: patient partnerships.  

“The question ASCO is asking this year, which is really important, is ‘so what?’ How does that benefit the patients?” Tennant explained, adding that Astellas is carrying out its mission to benefit patients.

It's halfway through the year, and the drugmaker already has one of the approvals under its belt. In early April, the FDA granted accelerated approval for Seagen and Astellas’ antibody-drug conjugate Padcev with Merck’s PD-1 king Keytruda as an initial therapy for adults with locally advanced or metastatic urothelial cancer. The approval is for patients who don’t qualify for cisplatin-based chemotherapy. To keep hold of the accelerated approval, the pharma has to verify the combo’s worth in a phase 3 readout later this year.

“We're able to not only talk the talk, but walk the talk,” Tennant said.

Astellas’ newest hopeful on the block is a monoclonal antibody called zolbetuximab, which scored a second phase 3 win this spring and secured front-runner status in the race to deliver a drug against one of the hottest targets in cancer. Data from that phase 3 trial—known as GLOW—were shared at this year’s ASCO meeting. The placebo-controlled study found that adding zolbetuximab to a chemotherapy regimen improved the progression-free survival (PFS) rate, which was the main goal of the trial, alongside overall survival in CLDN18.2-positive, HER2-negative cancer patients.

This follows similar results shared in November 2022 from a phase 3 trial known as SPOTLIGHT. The earlier study linked the anti-CLDN18.2 antibody to improved PFS in gastric and gastroesophageal junction cancer patients.

The two studies targeted the same populations and enrolled similar numbers of patients: 507 in GLOW versus 565 in SPOTLIGHT. The key difference was the choice of chemotherapy regimen.

The double success has given Astellas ammunition to ask the FDA for approval.

“We're in discussions with regulators,” Tennant shared. “And we hopefully will have news on that in the not-too-distant future.”

Tennant said the pharma will be meeting with regulators across the globe about zolbetuximab, though he noted that he’s only involved in the U.S. side of things. Barring any regulatory hiccups, Astellas will become the first company to bring an anti-CLDN18.2 drug to market. Behind the Japanese drugmaker is a long list of drug developers tackling the target using a wide variety of modalities, with AstraZeneca alone penning two deals in the past year for an antibody-drug conjugate and a bispecific antibody against CLDN18.2.

Astellas is also aiming for approval of an Xtandi and leuprolide combo for men with non-metastatic hormone-sensitive prostate cancer (nmHSPC) with high-risk biochemical recurrence (BCR). Pfizer-partnered Xtandi is currently approved to treat prostate cancer but hasn’t been cleared by any regulatory agency for patients with nmHSPC and high-risk BCR. Leuprolide is used to treat endometriosis, uterine fibroids or prostate cancer.

The drugmaker plans to bring phase 3 data that found the combo significantly reduced the risk of metastasis or death by 58% versus placebo plus leuprolide to the attention of regulatory authorities this summer in hopes of expanding Xtandi’s label.

“It’s an exciting year or two ahead of us—a busy year, a few more gray hairs if I can fit any more in,” Tennant said with a chuckle.