The support for the marketing authorization is from the multinational, single-arm, Phase 2 open-label ZUMA-2 pivotal trial in patients with relapsed or refractory mantle cell lymphoma who had previously received anthracycline- or bendamustine-containing chemotherapy, anti-CD20 antibody therapy, and a BTK inhibitor.

ZUMA-2

ZUMA-2 is an ongoing, multinational, single-arm, Phase 2 open-label pivotal trial. The study enrolled 74 adult patients with relapsed or refractory mantle cell lymphoma who had previously received anthracycline- or bendamustine-containing chemotherapy, anti-CD20 antibody therapy and a BTK inhibitor (ibrutinib or acalabrutinib).

The treatment was manufactured for 71 patients and administered to 68 patients. The primary endpoint was the objective response rate per the Lugano Classification (2014), defined as the combined rate of complete response and partial responses as assessed by an Independent Radiologic Review Committee.

ZUMA-2 demonstrated an overall response rate (complete or partial) of 93%, 67 % of patients achieved a complete response, as assessed by an Independent Radiologic Review Committee following a single infusion of Tecartus.

In the safety analyses, Grade 3 or higher cytokine release syndrome (CRS) and neurologic events were observed in 15% and 33% of patients, respectively.

A Quote from Professor John G. Gribben

Professor John G. Gribben, Consultant Haematologist and Medical Oncologist at Barts and The London NHS Trust, London, said, “Significant gaps in treatment remain for patients with mantle cell lymphoma who progress following initial therapies. The availability of this first cell therapy for relapsed or refractory mantle cell lymphoma, following at least two lines of systemic therapy including a BTK inhibitor, provides an important option for patients in Europe.”

Mantle Cell Lymphoma

Mantle cell lymphoma is a rare form of non-Hodgkin lymphoma that arises from cells originating in the “mantle zone” of the lymph node and predominantly affects men over the age of 60. Patients with relapsed or refractory mantle cell lymphoma after two or more lines of systemic therapy, including a BTK inhibitor, have a poor prognosis with a median overall survival of 6 to 10 months. In Europe it is estimated that at least 7,400 people are diagnosed with mantle cell lymphoma each year.

The Product, Tecartus™

Tecartus is a CAR T-cell therapy – an individualized method of treatment that harnesses the body’s own immune system to target cancer cells. The therapy uses the XLP™ manufacturing process that includes T cell enrichment, a necessary step in certain B cell malignancies in which circulating lymphoblasts are a common feature.

Tecartus was granted Priority Medicines (PRIME) designation by the EMA in recognition of its potential to benefit patients with a significant unmet medical need,

Conditional marketing authorization in Europe is initially valid for one year but can be extended or converted into an unconditional marketing authorization after the submission and assessment of additional confirmatory data. Conditional approval is granted to a medicinal product that fulfills an unmet medical need where the benefit of immediate availability outweighs the risk of less comprehensive data than normally required.

It requires additional monitoring and post-marketing data before full approval is granted.

For full details on the Special Warnings and Precautions for Use and Adverse Reactions (including appropriate management) please refer to the EU Summary of Product Characteristics (SmPC). 

Prohost Observations 

One does not have to be a condemned patient, after the main cancer treatments have been exhausted, to know the importance of the CAR T-cell therapy Tecartus. Such a drug brings hope back to the patients who have otherwise lost it with nothing but death on the horizon.  

Good news also for Gilead Sciences. 

Gilead Sciences and Galapagos NV

• Gilead and Galapagos announce a new Commercialization and Development agreement for Jyseleca® (filgotinib)
• Gilead will not advance Jyseleca for the Treatment of Rheumatoid Arthritis (RA) in the U.S. following FDA Type A meeting.
• Galapagos to assume sole responsibility in Europe for Jyseleca in RA and Ulcerative Colitis (UC) plus future indications.
• Gilead to receive royalties on European sales starting in 2024.
• Galapagos to assume responsibility for majority of ongoing clinical trials.
• Gilead will pay Galapagos €160 million to support ongoing development and accelerated commercial buildout in EU.

Gilead Sciences and Galapagos NV (GLPG) announced a new agreement to amend their existing arrangement for the commercialization and development of Jyseleca (filgotinib). This announcement follows a Type A meeting with the U.S. FDA to discuss the points raised in the Complete Response Letter (CRL) related to the New Drug Application (NDA) for filgotinib in the treatment of RA.

Based on the feedback received from the FDA during the NDA review process and in the Type A meeting, Gilead decided not to pursue FDA approval of filgotinib for RA. While both Gilead and Galapagos continue to believe in the clinical profile of the 200 mg dose, Gilead has concluded that this dose is required to be competitive in rheumatoid arthritis in the United States and that the 200 mg dose is unlikely to achieve approval for the product RA in the U.S. without conducting substantial additional clinical studies.

Under the new arrangement between the companies, Galapagos will assume sole responsibility in Europe for filgotinib in RA, where 200 mg and 100 mg doses are approved for moderate to severe RA, and in all other future indications.

Galapagos will receive payments from Gilead in connection with changes in responsibility for the commercialization and development of filgotinib in Europe

Gilead will receive royalties from European sales of filgotinib. This is an acceleration of the commercial strategy in place for products under the separate ten-year research and development collaboration between the companies, where Galapagos is also responsible for European commercialization.

Through a phased transition including the transfer of filgotinib’s marketing authorization to Galapagos, the majority of activities supporting filgotinib in Europe are expected to be assumed by Galapagos by the end of 2021.

Under the new operating model, Gilead will retain commercial rights and remain a marketing authorization holder for filgotinib outside of Europe, including in Japan where filgotinib has recently been approved and co-marketed with Eisai.

From the Chairman & CEO of Gilead Sciences

Daniel O’Day, Chairman and Chief Executive Officer, Gilead Sciences, said this about the subject, “While we believe that the clinical profile of Jyseleca (filgotinib) could help many patients living with rheumatoid arthritis, we no longer see a viable path to U.S. approval in this indication. In this new context, Gilead and Galapagos believe it makes sense for Galapagos to drive commercialization in Europe. We are confident that through our strategic alliance with Galapagos, we will deliver many important new therapies for inflammatory diseases in the future.”

From the CEO of Galapagos NV

Onno van de Stolpe, Chief Executive Officer of Galapagos, said, “Jyseleca (filgotinib) is already providing an important new treatment option, making a difference to the lives of patients living with RA, where it is available in Europe. While we are very disappointed by the outcome of the FDA meeting, we are excited that we can now accelerate the plan for Galapagos to lead on commercial activities in Europe in our ongoing collaboration with Gilead, and fully leverage the commercial organization Galapagos has built for the Jyseleca launch. This is an important new chapter in Galapagos’ ongoing journey to be a leading European biotech company in inflammation and fibrosis.”

Gilead and Galapagos recently paused clinical trials of filgotinib in psoriatic arthritis (PsA), ankylosing spondylitis (AS) and non-infectious uveitis following receipt of the CRL and, without a viable path forward in the United States, the companies no longer believe it is feasible to continue the current global development program for filgotinib in these indications.

As a result, these trials will be stopped over the coming months.

To learn more about the Gilead and Galapagos relationship, based on their new agreement, please read the firm’s press release by clicking here.

To read more about Gilead Sciences please click here.