by Jakub Jarolím, Business Intelligence Department
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SOTIO Biotech
23/11/2021
September 2021 Review of news from the most innovative therapeutic areas and the business development transactions
Market
Stocks experienced decline in September as inflation fears persist
Global stock markets experienced fall as inflation fears persisted and expectations grew that the US Federal Reserve would tighten policy in the coming months. Earlier in the month, global shares suffered their worst rout since January. The Nasdaq Biotech Index lost 5 %.
Antibody-Drug Conjugates
FDA granted accelerated approval to Tivdak in cervical cancer
Astellas and Seagen win Japanese approval for Padcev in advanced urothelial cancer
Astellas and Seagen announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved Padcev (enfortumab vedotin) for radically unresectable urothelial carcinoma that has progressed after anti-cancer chemotherapy. The New Drug Application received priority review. The approval is primarily based on the global Phase 3 EV-301 clinical trial, which included sites in Japan. The trial evaluated enfortumab vedotin versus chemotherapy in adult patients with locally advanced or metastatic urothelial cancer who were previously treated with platinum-based chemotherapy and a PD-1/L1 inhibitor. Median overall survival was 12.9 vs. 9 months.
Interleukin-15 and Interleukin-2
IL-15 superagonist N-803 achieved strong antitumor activity in bladder cancer
ImmunityBio announced updated data from an ongoing bladder cancer trial showing sustained complete response rates in patients with BCG-unresponsive non-muscle invasive carcinoma in situ bladder cancer (Cohort A). Of the 81 patients in the QUILT 3.032 study, 58 patients (72%) had a complete response (CR) at any time (three or six months) to intravesical BCG plus N-803 (Anktiva) with median duration of CR of 19.9 months. The data also showed a 59% probability (95% confidence interval; 43.1%, 71.2%) that responding patients would maintain a complete response for more than 12 months, based on Kaplan-Meier analysis. For the patients who had a CR within the first three months, the CR rate was 77%, with a 61% probability of remaining disease free at 18 months with the median duration of complete response having not yet been reached in that group. 85% of patients in the cohort avoided a cystectomy with a median duration of follow-up of 20.4 months. Of note, the therapy was extremely well tolerated with 0% treatment-related SAEs, 0% immune-related AEs and 0% grade 4 or 5 treatment-related AEs. In contrast, the currently approved checkpoint therapy for this indication is associated with an incidence of 21% immune-related adverse events.
Cell Therapies
NMPA approved China’s first independently developed CAR-T therapy Relma-cel
JW Therapeutics announced that the NMPA of China has approved the NDA for its anti-CD19 autologous CAR-T cell immunotherapy product relmacabtagene autoleucel injection for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy and has released the drug registration certificate.
Relma-cel is the first CAR-T product approved as a Category 1 biologics product in China, and sixth approved CAR-T product globally. The product was independently developed based on a CAR-T cell process platform of Juno Therapeutics to meet the needs of the Chinese market. Currently, it is the only approved CAR-T product in China that has been simultaneously included in the National Significant New Drug Development Program, granted Priority Review and Breakthrough Therapy designations (in follicular lymphoma).
Other Innovative Treatment Areas
Opdivo approved as first immunotherapy for first-line advanced gastric cancer in China
Opdivo is now the first and only immunotherapy for the first-line treatment of advanced gastric cancer in China. Opdivo, in combination with fluorouracil and platinum-based chemotherapy, received marketing approval from the NMPA for the initial treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma. It is also the only PD-1 inhibitor that has obtained marketing approval for the treatment of gastric cancer in China.
Its efficacy was evaluated in a multicenter, randomized, open-label Phase 3 trial Checkmate-649, which enrolled 2,687 patients from March 2017 to April 2019 and concurrently randomly assigned 1,581 patients to treatment. The median follow-up for OS was 13.1 months for Opdivo plus chemotherapy and 11.1 months (5.8–16.1) for chemotherapy alone.
Oncology Transactions
Adaptimmune strikes $3 billion deal with Genentech to develop T cell therapies
M&As
Sanofi takes out Kadmon for $1.9 billion gaining transplant drug and IL-15 fusion protein
Sanofi has entered into a definitive merger agreement with Kadmon Holdings. The acquisition will immediately add Rezurock (belumosudil) to its transplant portfolio. Rezurock is a recently FDA-approved, first-in-class treatment for chronic graft-versus-host disease for adult and pediatric patients 12 years and older who have failed at least two prior lines of systemic therapy.
Shareholders of Kadmon common stock will receive $9.50 per share in cash, which represents a total equity value of approximately $1.9 billion. Rezurock’s label could gain at least one additional indication. Data are due by year-end from an open-label Phase II trial of the therapy to treat systemic sclerosis. A separate placebo-controlled Phase 2 trial is also enrolling patients. Also in the pipeline lies anti-PD-L1/IL-15 fusion protein KD033, which is in Phase 1 testing for immuno-oncology.
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