by Jakub Jarolím, Business Intelligence Department
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Sotio Biotech
2/11/2021
August 2021 Review of news from the most innovative therapeutic areas and the business development transactions
Market
Comirnaty full approval, pandemic antibodies advances, and big deals drive stock prices up
A full approval for Pfizer’s Comirnaty vaccine, clinical advances of pandemic antibodies from Regeneron and AstraZeneca, and multibillion dollar deals announced by Pfizer or Seagen appear to be the driving forces of increasing biopharma stock prices. NBI added 4 % during August.
Antibody-Drug Conjugates
Enhertu beats Kadcyla in head-to-head breast cancer trial
Positive high-level results from the DESTINY-Breast03 Phase 3 trial showed that Enhertu (trastuzumab deruxtecan), the AZ and Daiichi Sankyo HER2-directed ADC demonstrated superiority over Kadcyla (trastuzumab emtansine). At a planned interim analysis, the IDMC concluded that the trial met the primary endpoint of PFS showing a highly statistically significant and clinically meaningful improvement for patients with HER2-positive, unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane.
Enhertu also showed a strong trend toward improved OS compared to Kadcyla in a key secondary endpoint, although the OS data are still immature. The safety profile of Enhertu was consistent with previous clinical trials, with no new safety concerns identified and no Grade 4 or 5 treatment-related interstitial lung disease events. Data will be shared at an upcoming medical meeting and filed with regulators.
The results could move Enhertu further to the front in the treatment line for HER2-positive breast cancer, as it is already approved for patients who have received two or more previous anti-HER2 therapies.
Interleukin-15 and Interleukin-2
Alkermes received Fast Track for IL-2 therapy nemvaleukin alfa against mucosal melanoma
Alkermes announced that FDA has granted Fast Track designation to nemvaleukin alfa, the company's novel, investigational engineered interleukin-2 (IL-2) variant immunotherapy, for the treatment of mucosal melanoma.
Cell Therapies
EMA approved Abecma CAR-T therapy for treatment of advanced multiple myeloma
EMA has granted conditional marketing authorization to Abecma idecabtagene vicleucel by BMS to treat relapsed and refractory multiple myeloma in adults who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.
Other Innovative Treatment Areas
FDA approved Opdivo for adjuvant treatment of patients with high-risk urothelial carcinoma
Opdivo 240 mg every two weeks or 480 mg every four weeks was approved by FDA for the adjuvant treatment of patients with urothelial carcinoma who are at high risk of recurrence after undergoing radical resection, regardless of prior neoadjuvant chemotherapy, nodal involvement or PD-L1 status.
The approval is based on the Phase 3 CheckMate -274 trial, which compared Opdivo 240 mg (n=353) to placebo (n=356). In the trial, among patients who received Opdivo, median disease-free survival was nearly twice as long as in those who received placebo (20.8 months versus 10.8 months). Opdivo reduced the risk of disease recurrence or death by 30% compared to placebo.
Among patients whose tumors express PD-L1 ≥1%, median disease-free survival was not reached for those who received Opdivo versus 8.4 months for placebo; Opdivo reduced the risk of disease recurrence or death by 45%.
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