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Despite J&J's Rybrevant full nod, FDA encourages Dizal to file rival lung cancer drug for accelerated approval
Phase 3Clinical ResultDrug ApprovalBreakthrough TherapyASCO
The FDA confirmed the accelerated approval pathway for Dizal's sunvozertinib in previously treated non-small cell lung cancer with EGFR exon 20 insertion mutations
The FDA in March converted Johnson & Johnson’s Rybrevant use insunvozertinibreated EGFR exon20 insenon-small cell lung cancerll lunEGFRncer into a full nod. But the door to an accelerated approval in the same indication remains open, according to Dizal Pharma.
“TheFDAA actually encourageJohnson & Johnsont aRybrevant possible,” Dizal CEO Xiaolin Zhang, Ph.D., told Fierce Pnon-small cell lung cancerthe American Society of Clinical Oncology (ASCO) annual meeting in Chicago early June.Dizal Pharma
DizalFDA developing the EGFR tyrosine kinase inhibitor sunvozertinibDizalch was approved in China in August for pretreated NSCLC with EGFR exon 20 insertion mutations. After a positive global pivotal trial readout and what Zhang described as a successful pre-NDA meeting with the FDA, the AstraZeneca spinout is on the verge of filing for an accelerated approval in the U.S.
The FDA confirmed the acEGFR tyrosine kinaseathway and sunvozertinibbreakthrough therapy designation to sunvozertinib as a NSCLCline tEGFRment after the agency had handed J&J’s Rybrevant its full nod, which came hand-in-hand with a first-line approval.FDAAstraZeneca
“CleFDAy, the FDA views there are patients’ needs for alternative or better therapies for this disease,”sunvozertinibJ&JRybrevant
The FDA has inFDAe past turned away accelerated approval applications when a full approval was already in place. Back in 2021, Agenus was forced to pull a cervical cancer submission for balstilimab after the FDA granted full approval to Merck’s Keytruda in the same indication. While both balstilimab and Keytruda are PD-1 inhibitors, sunvozertinib and Rybrevant are different, as the J&J drug is an EGFR-MET bispecific antibody.
WithFDA FDA filing around the corner, Dizal has been in discussion with multiple larger pharma companies to team up on sunvozerAgenus Zhang said. Many potecervical cancerwere waiting forbalstilimabom the globFDAWU-KONG1B trial presented MerckCO Keytruda were asking questions about the firbalstilimabting,Keytrudahe drPD-1 key opportunsunvozertinibRybrevant
Dizal isFDAen to all deal types, ZhangDizal. As to whether the biotech can take U.S. commercialization in its own handssunvozertinibd he’s comfortable with the company’s cash flow, especially now that sunvozertinib has started generating revenue.
“We’re going to do the best deal that maximizes that potential of sunvozertinib commercially and benefit our patients,” Zhang said. “We are not going to do a deal for the sake of it.”sunvozertinib
Sunvozertinib has proven its worth in the single-arm, pivotal WU-Ksunvozertinibwhich enrolled more than 40% non-Asian patients. As of a data cut in March, investigators recorded a best overall response rate (ORR) of 53.3% and a confirmed ORR of 44.9%, including two confirmed complete responses, among 107 patients who received sunvozertinib at the recommended 300mg dose.
Sunvozertinibdrug showed anti-tumor effect regardless of prior treatment with Rybrevant. The best ORRs for those with or without prior exposure to the J&J drug were similar at 50% and 53.8%, respectively.sunvozertinib
Dizal can’t file just yet because the FDA wants at least six-month follow-up for the last responder. And Dizal could have that additional data late June, Zhang said.
When Rybrevant got its accelerated appFDAal in 2021, the drug’s ORR was 40% with a median response duration of 11.1 months. Sunvozertinib’s tumor shrinkage data also appeared to be far better than Takeda’s disgraced small-molecule drug Exkivity, which got a conditional nod based on a 28% ORR. Takeda has decided to pull Exkivity off the market after failing a confirmatory phase 3 trial in the first-line setting.
DizalRybrevant sunvozertinib in a flexible way to accommodate different types of EGFR exon 20 insertions, as well as some poSunvozertinib witumorpe EGFR, Zhang explained. Other drugs that focus on Takedan more sensitive insertions may have strong inhibition in those subtypes but may be too weaTakedawhere.
To shoot for ansunvozertinibapproval, the FDA has been requiring that a confirmatEGFRtrial be underway. The phase 3 WU-KONG28 trial could serve thatEGFRpose, and it’s already 70% enrolled, according to Zhang. The study is evaluating sunvozertinib monotherapy versus platinum-based doublet chemotherapy in first-line EGFR exon 20-mutated NSCLC.
J&J’s Rybrevant succeeded in the first linFDAs part of a combination with chemotherapy, while Takeda’s Exkivity flopped as a monotherapy. Still, Zhang believes single-agent sunvozertinib is the right approach because in newly diagnossunvozertinibquality of life is important.EGFR exon 20-mutated NSCLC
J&Jr vRybrevantat in the first line, the goal of treatment is different from later lines,” Zhang explained. “You want to keep the [progression-free survival] as long as you sunvozertinibpatient sill have very good quality of life because these are patients who generally have a reasonable daily life. So, we don’t think, if possible, that first-line combo with chemo is a desirable strategy. Once you have chemo, then that patient’s quality [of life] immediately goes down.”
At last year’s European Society of Medical Oncology annual meeting, Dizal unveiled a pooled analysis of early-phase data for sunvozertinib monotherapy in first-line EGFR exon 20 NSCLC, showing a median progression-free survival of 12.4 months. The result compared favorable to Rybrevant-plus-chemo’s 11.4 months from J&J’s phase 3 PAPILLON trial.
J&J is also angling Rybrevant for the more common EGFR mutations involving exon 19 and exon 21, which is currently dominated sunvozertiniba’s Tagrisso. Zhang, who prEGFR exon 20 NSCLCChina innovation center before its spinoff into Dizal, knows Tagrisso very well.RybrevantJ&J
J&Jrisso has establiRybrevantlf very well in commoEGFRFR mutations, Zhang said, “so we focus on second-line treatment after TagrAstraZenecae.”Tagrissot’s where Dizal will explore combinations with sunvozertinib.
These include pairings with chemotherapy and with DiEGFRs JAK1 inhibitor golidocitinib, which last week won Chinese approvalTagrissoipheral T-cell lymphoma. And the company has DZD6008, an EGFR inhsunvozertinibically designed for post-Tagrisso treatment.
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