It has been a big month for the oncology space, underpinned by several US approvals in haematological and solid tumour indications – with BeOne Medicines, Taiho Oncology and Arvinas all securing the regulatory greenlight for their respective cancer drugs.
In the haematology space, the US Food and Drug Administration (FDA) approved Taiho’s combination acute myeloid leukaemia (AML) pill, Inqovi (decitabine/cedazuridine) plus venetoclax, in newly diagnosed adults aged 75 and up who cannot undergo induction chemotherapy.
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This decision was based on the outcomes of the Phase III ASCERTAIN-V study (NCT04657081), where 42 (41.6%) patients receiving Inqovi plus venetoclax achieved complete remission (CR). The median duration of CR was not reached.
Inqovi-venetoclax’s approval comes as researchers estimate that more than half of patients newly diagnosed with AML are not considered for intensive induction therapy due to their age and comorbid conditions – meaning there is a significant need for more tolerable treatment regimens in elderly and potentially frail populations.
According to Taiho Oncology’s CMO, Harold Keer, Inqovi-venetoclax’s fully oral status could “reduce the overall treatment burden” associated with trips to the hospital or clinic, which are necessary for patients receiving intravenous (IV) therapies.
Following Inqovi’s approval in AML, the drug is now available across three blood cancer indications, as the FDA previously greenlit it for use in patients with Myelodysplastic Syndromes (MDS), including Chronic Myelomonocytic Leukemia (CMML), in July 2020.
BeOne’s Beqalzi enters BCL2 arena
In another win for haematological cancer patients in the US, BeOne Medicines secured FDA accelerated approval for Beqalzi (sonrotoclax) in relapsed or refractory mantle cell lymphoma (R/R MCL). The next-generation B-cell lymphoma 2 (BCL2) inhibitor is suitable for patients who have received at least two lines of therapy, including treatment with a mainstay Bruton’s tyrosine kinase (BTK) inhibitor.
Beqalzi secured accelerated approval based on results from its Phase I/II BGB-11417-201 (NCT05471843) trial, in which the drug elicited an overall response rate (ORR) in 52% of patients, while prompting a CR rate of 16%.
Upon its regulatory win, BeOne claims that Beqalzi is the first drug in its class to reach the market in R/R MCL – offering patients in the post-BTK inhibitor setting a new option with a targeted mechanism. This comes as MCL patients with relapsed or refractory disease are prone to poor outcomes, which is especially true for patients that progress early after frontline therapy, says a paper published in Blood Advances.
To gain full approval for Beqalzi in R/R MCL, BeOne will need to confirm the drug’s clinical benefit in the global CELESTIAL-RRMCL study (NCT06742996), which is currently underway in 149 locations across 17 countries, as per ClinicalTrials.gov.
FDA’s May oncology approval spree
Alongside the Inqovi-venetoclax and Beqalzi approvals, the FDA has greenlit two other oncology drugs thus far in May, including Arvinas’ Veppanu (vepdegestrant) for a form of breast cancer on 1 May. Up to now, all the novel drugs approved by the agency this month have been in the oncology realm.
On the first day of the month, the agency approved Veppanu alongside Guardant360’s ESR1 mutation-detecting companion diagnostic (CDx) device for use in adults with advanced or metastatic, human epidermal growth factor receptor 2 (HER2)-negative, oestrogen receptor (ER)-positive, ESR1-mutated breast cancer.
The protein degrader-CDx combo’s market authorisation comes as companion diagnostic approaches gain significant traction in the oncology space, as companies tout their potential to improve and personalise cancer care to a patient’s genetic makeup and disease profile.
The other oncology approval earlier this month was Partner Therapeutics’ Bizengri (zenocutuzumab), which the FDA gave accelerated approval for in a type of bile duct cancer on 8 May. Partner secured an expedited review for Bizengri due to the Commissioner’s National Priority Voucher (CNPV) scheme, which hangs in the balance following the resignation of the scheme’s creator and former FDA chief, Marty Makary.
