- The company reported the voluntary withdrawal of the Imfinzi (durvalumab) indication in the US for prior treated adult patients with LA or metastatic bladder cancer. The withdrawal was made in consultation with the US FDA
- The withdrawal is aligned with FDA guidance for evaluating indications with accelerated approvals that did not meet post-marketing requirements
- In May’2017, Imfinzi has received accelerated approval in the US based on Study 1108 while the continued approval was contingent on results from the P-III DANUBE study in the 1L metastatic bladder cancer setting, which did not meet its 1EPs in 2020
Click here to read full press release/ article | Ref: AstraZeneca | Image: Healthline
The post AstraZeneca to Withdraw Imfinzi Indication in Advanced Bladder Cancer in the US first appeared on PharmaShots.
AstraZeneca has suffered a setback after it voluntarily withdrew its cancer immunotherapy Imfinzi (durvalumab) in a bladder cancer indication in the US.
AZ’s share price ticked downwards after the announcement that it will stop marketing Imfinzi, a PD-L1 class immunotherapy, for previously treated adult patients with advanced or metastatic bladder cancer.
It’s news that will likely hand market share to Roche and Pfizer/Merck KGaA, whose respective immunotherapies Tecentriq and Bavencio have bladder cancer indications.
In a statement, the big UK pharma said it had made the decision in consultation with the FDA, which was running the rule over results from the phase 3 DANUBE trial.
Following an accelerated approval in 2017 based on earlier clinical data DANUBE was supposed to supply the confirmatory survival data for Imfinzi’s first line bladder cancer indication.
But in March last year AZ announced that DANUBE had failed to meet its overall survival endpoints compared with standard care in advanced bladder cancer patients with high levels of the PD-1 biomarker, or patients regardless of their PD-1 status.
The trial tested Imfinzi as monotherapy and as part of a combination with AZ’s CTLA-4 immunotherapy and neither showed an improvement over standard care.
AZ said that the withdrawal is aligned with FDA post-approval guidance, where trial data did not meet post-approval requirements.
The news will come as a blow for AZ, where Imfinzi has been an important component of the company’s cancer portfolio.
In full year 2020 results the drug generated over $2 billion, with US sales of just under $1.2 billion.
AZ did not provide sales by indication but Imfinzi is also approved in unresectable stage III non-small cell lung cancer after chemoradiation therapy in the US and other markets, based on data from the PACIFIC phase 3 trial.
It is also approved in extensive stage small cell cancer in the US and other markets based on findings from the CASPIAN phase 3 trial.
It is also being tested in a range of other cancers, including in combination with tremelimumab, liver cancer, biliary tract cancer, oesophageal cancer, ovarian cancer and other solid tumours.
The post AZ withdraws Imfinzi in US bladder cancer use after trial failure appeared first on .
- The P- III KESTREL trial involves assessing of Imfinzi (durvalumab) or Imfinzi + tremelimumab vs EXTREME treatment regimen (CT+ cetuximab) in patients as a 1L treatment for patients with recurrent or m-HNSCC whose tumors expressed high levels of PD-L1
- The trial failed to meet its 1EPs of improving OS while the combination did not indicate an OS benefit in all-comer patients as 2EPs. The safety & tolerability for Imfinzi as a monothx. and in combination were consistent with previous trials
- Imfinzi is a human mAb that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumor’s immune-evading tactics and releasing the inhibition of immune responses
Click here to read full press release/ article | Ref: AstraZeneca | Image: AstraZeneca
The post AstraZeneca’s Imfinzi Fails to Meet its Primary Endpoints in P-III KESTREL Study first appeared on PharmaShots.
- AstraZeneca’s Imfinzi durvalumab (1500mg, fd, q4w) is recommended for approval in the EU for an additional dosing option in the approved indication of LA, unresectable NSCLC in adults whose tumors express PD-L1 on at least 1% of tumor cells and whose disease has not progressed following platinum-based CRT
- The CHMP opinion is based on P-III PACIFIC trial that supported the 2wk, weight-based dosing of 10mg/kg q2w already approved in LA, unresectable NSCLC & the P-III CASPIAN trial which used fd, q4w during maintenance treatment in ES-SCLC
- The option would extend dosing from two to four weeks, reducing medical visits and improving patient convenience
Click here to read full press release/ article | Ref: AstraZeneca | Image: EORTC
The post EMA’s CHMP Recommends Four-Week Dosing Option for AstraZeneca’s Imfinzi to Treat Unresectable NSCLC first appeared on PharmaShots.
- The FDA has approved Imfinzi for an additional dosing option (1500mg, FD, q4w) in the approved indications of unresectable stage III NSCLC after CRT and prior treated advanced bladder cancer
- The approval is based on multiple studies, including the P-III PACIFIC study which supported the 2wks., wt. based dosing in unresectable stage III NSCLC, and the P-III CASPIAN study which used 4wks. FD, during maintenance treatment in ES-SCLC
- The new dosing option for Imfinzi is under regulatory review in multiple countries, including in the EU where the new dosing option was granted accelerated assessment
Click here to read full press release/ article | Ref: AstraZeneca | Image: Mint
The post AstraZenca’s Imfinzi (durvalumab) Receives the US FDA’s Approval for Less-Frequent Fixed-Dose Use first appeared on PharmaShots.
- The approval is based on P-III CASPIAN study assessing Imfinzi + etoposide and either carboplatin/ cisplatin CT or Imfinzi & CT+ tremelimumab vs CT as monothx. as 1L treatment in 805 patients with ES-SCLC. The trial used an FD of Imfinzi (1,500mg, q3w for 4 cycles) while in combination with CT and then q4w until disease progression
- Results: the study met its 1EPs of OS in Jun’2019, demonstrated a 27% reduction in risk of death with m-OS (13.0 vs 10.3 mos.); ORR (68% vs 58%). An updated analysis demonstrated sustained efficacy after a median follow up 2+ yrs., m-OS (12.9 vs 10.5 mos.)
- Imfinzi is a mAb targeting PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumor’s immune-evading tactics and releasing the inhibition of immune responses
Click here to read full press release/ article | Ref: AstraZeneca | Image: Clinical Lab Products
- The US FDA has accepted sBLA and granted PR to Imfinzi (1500mg) for a new 4wks. FD regimen to treat patients with unresectable Stage III NSCLC after CT and prior treated advanced bladder cancer, consistent with the approved dosing in ES-SCLC
- The company anticipates the PDUFA date in Q4’20. The sBLA is based on multiple clinical trials, including results of P-III CASPIAN trial in ES-SCLC which used the 4wks., FD regimen during maintenance
- If approved, the new dosing will be available as an alternative to the approved weight-based dosing of 10mg/kg q2w
Click here to read full press release/ article | Ref: AstraZeneca | Image: Fierce Pharma