The week was marked by a flurry of data presentations by several companies at the 59th annual meeting of the American Society of Hematology held between Dec 9 and Dec 12. The presentations also included new/updated data from ongoing clinical studies on different cancer candidates.
The major announcements included Regeneron Pharmaceuticals, Inc.’s REGN top-line data on phase II skin cancer candidate, Roche Holding AG’s RHHBY data on Tecentriq from phase III study in kidney cancer and on Venclexta from another phase III study in chronic lymphocytic leukemia (“CLL”).
Gilead Sciences Inc. GILD presented updated data on its CAR-T therapy, Yescarta. Novartis AG NVS also announced updated results from a phase III study on its CAR-T therapy, Kymriah. Moreover, Pfizer Inc.’s PFE PARP inhibitor demonstrated superiority over chemotherapy in a phase III study in breast cancer.
Let’s see the news in details.
Regeneron’s Cemiplimab Positive in Mid-stage Study: Regeneron along with partner Sanofi SNY announced that their checkpoint inhibitor targeting PD-1, cemiplimab, showed an overall response rate (“ORR”) of 46.3% in advanced cutaneous squamous cell carcinoma. The candidate was evaluated in a phase II study, EMPOWER-CSCC 1.
However, the median duration of response hasn’t been reached at the data cut-off date. The companies plan to file for a rolling Biologics License Application ("BLA") based on data from the study. (Read more: Regeneron, Sanofi Report Positive Top Line Skin Cancer Data)
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Roche Announces Data on Tecentriq and Venclexta: Roche announced positive results from the phase III IMmotion 151 study evaluating immuno-oncology drug Tecentriq in combination with chemotherapy, Avastin against Pfizer’s Sutent for first-line treatment of advanced or metastatic renal cell carcinoma. The combination therapy achieved statistically significant and clinically meaningful increase in progression free survival (“PFS”) compared to Sutent.
Data announced from another phase III study – MURANO – evaluating Venclexta plus Rituxan compared to bendamustine plus Rituxan in patients with relapsed or refractory CLL demonstrated significant reduction in the risk of disease progression or death in Venclexta arm. The MURANO study is being conducted with the aim of converting the current accelerated approval of Venclexta to a full approval. (Read more: Roche/AbbVie Report Positive Phase III Results on Venclexta)
Updates on Two Approved CAR-T Therapies: Gilead announced long-term follow-up data from a phase II study, evaluating its chimeric antigen receptor T-cell (CAR-T) therapy, Yescarta. The phase II ZUMA-1 study is evaluating the therapy in refractory large B-cell lymphoma. Data showed that a single infusion of Yescarta achieved an overall response rate (“ORR”) of 42% at a median follow-up of 15.4 months.
Novartis is evaluating its CAR-T therapy, Kymriah, in phase III JULIET study in adult patients with a difficult-to-treat cancer- relapsed or refractory diffuse large B-cell lymphoma.Data showed that at six months, 30% of patients treated with Kymriah showed complete response. The relapse-free probability at six months after first response was 74%. Median overall survival was not achieved and the median time from infusion to data cutoff was 5.6 months. (Read more: Novartis Reports Updated Results from Kymriah's JULIET Study)
Apart from these, bluebird bio, Inc. BLUE and Juno Therapeutics announced additional/follow-up data on their CAR-T therapies, which are in phase I studies. Bluebird’s candidate, bb2121, achieved an objective response of 94% and complete response of 54%. The Juno’s candidate, JCAR017, showed an ORR and 68% complete response (“CR”) rate at three months
Pfizer’s PARP Inhibitor Superior in Breast Cancer Study: Pfizer is developing its PARP inhibitor, talazaporib, in phase III EMBRACA study in patients with germline BRCA-positive breast cancer against chemotherapy. The candidate achieved a significant reduction of 46% in the risk of disease progression as the median PFS was 8.6 months in the talazoparib arm versus 5.6 month in the chemotherapy arm. (Read more: Pfizer's Talazoparib Emerges Superior in EMBRACA Study)
Apart from these news, Bristol-Myers announced data on Sprycel, which is being evaluated in a phase II study in Philadelphia chromosome-positive acute lymphoblastic leukemia. Sprycel, following its addition to a chemotherapy regimen, achieved an event-free survival rate of 65.5% and an ORR of 91.5% after three years.
Moreover, the FDA granted priority review to Merck’s supplemental BLA looking for label expansion of Keytruda to include refractory primary mediastinal B-cell lymphoma, a type of non-Hodgkin lymphoma.
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