Overwhelming success of Gilead/Kite’s Yescarta; Ridgeback/ Merck in the COVID-19 game; AnaptysBio’s antibody-drug failure; Roche discards Tecentriq for bladder cancer

Posted on Mar 9, 2021 by Delveinsight

Gilead/Kite's Yescarta; Roche discards Tecentriq for bladder cancer

Gilead’s Kite Receives Expanded Approval for its CAR-T Yescarta’s in Follicular Lymphoma 

Gilead’s Kite has successfully secured success in launching the first-ever chimeric antigen receptor (CAR) T-cell therapy in the Follicular Lymphoma Market. The US FDA approved the Yescarta for adults with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy under accelerated approval. 

Also known as axicabtagene ciloleucel, Yescarta’s approval is based on the results from the study ZUMA-5. In this single-arm, open-label trial, 91% of patients with r/r FL responded to the treatment, including an estimated 74% of them in continued remission at 18 months. However, the therapy will come with a boxed warning for cytokine release syndrome and neurologic toxicities. 

Follicular Lymphoma is a type of indolent non-Hodgkin lymphoma (iNHL) in which malignant tumors grow gradually and turn aggressive with time. It is the most common form of indolent lymphoma and the second most common type of lymphoma around the world. 

Yescart has already been ok’d for relapsed or refractory large B-cell lymphoma, as well as for relapsed or refractory mantle cell lymphoma in combination with Tecartus.

Promising data from COVID-19 trial, reports Ridgeback and Merck 

Merck and Ridgeback Biotherapeutics released preliminary data from a Phase IIa trial investigating oral antiviral agent molnupiravir EIDD-2801/MK-4482 for Covid-19. 

An oral ribonucleoside analog, Molnupiravir, inhibits the replication of multiple RNA viruses, including SARS-CoV-2. The therapy has demonstrated activity in several models of COVID-19, including for prophylaxis, treatment, and prevention of transmission. It has also shown activity in SARS-CoV-1 and MERS. 

The candidate was invented at Drug Innovations at Emory (DRIVE), LLC, a not-for-profit biotechnology company wholly owned by Emory University. Ridgeback. It was then licensed to Ridgeback Biotherapeutics, which obtained funding from Wayne and Wendy Holman, and Merck for its development. 

AnaptysBio’s shares plummeted after its lead drug fails in rare skin inflammation phase II trial 

AnaptysBio shares fell owing to discouraging news of its antibody-drug, imsidolimab, failure in a rare inflammatory skin condition. The company announced that the drug did not prove to be upbeat. In Phase II clinical trial, imsidolimab failed to meet primary endpoints moderate-to-severe palmoplantar pustulosis (PPP). The POPLAR trial, however, showed that the drug is well-tolerated with no serious or severe side effects. 

Palmoplantar pustulosis is a rare, recurring inflammatory disorder that is characterized by crops of sterile pustules on one or both hands and feet. The skin, later on, gets thick, scaly, and red with painful cracks. It is often seen in combination with plaque psoriasis. 

However, the boat has not sunk for imsidolimab. The company is evaluating imsidolimab in other five other immuno-dermatological indications such as acne, EGFRi-mediated skin toxicities, ichthyosis, hidradenitis suppurativa

After AZ, Roche discards Tecentriq for Bladder cancer treatment 

A few days back, AstraZeneca pulled out its candidate Imfinzi for the treatment of bladder cancer, a swiss pharma, Roche, also dropped its plans to proceed with its checkpoint inhibitor Tecentriq (atezolizumab) for the same. 

Roche was evaluating Tecentriq in prior-platinum treated metastatic urothelial carcinoma (mUC). It had received accelerated approval by the USFDA for the same indication in 2016, which was based on the results from a cohort in the IMvigor210 study. However, after its therapy failed to meet endpoints in confirmatory trials, the company decided to ditch it voluntarily.

However, this decision of the company does not affect any other approved status of the therapy for other indication that includes non-small cell lung cancer, small cell lung cancer, certain types of bladder cancer, a kind of triple-negative breast cancer, and liver cancer.

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